Revisiones para IVD in colon cancer | Registro Público Cubano de Ensayos Clínicos

--- 4 Abril 2025 - 9:39am por HHA
+++ 9 Marzo 2026 - 11:50am por HHA
-Recruiting
+Complete
--12-22 00:00:00
+-09-16 00:00:00
-Inflammatory biomarker levels. IL-6 (will be measured in PG/ML), C-reactive protein (will be measured in mg/L), CEA tumor marker (will be measured in ng/mL). Measurement time: basal, 15 days, week 12, week 24.
+Levels of inflammatory biomarkers. IL-6 (measured in pg/mL), C-reactive protein (measured in mg/L), tumor marker CEA (measured in ng/mL). Measurement time: baseline, 8 weeks.
-Quality of life (EORTC QLQ-CR30 Quality of Life Survey). Measurement time: baseline, 15 days, week 12, week 24 and 2 months after the end of treatment.
+I. Perioperative evolution:
-Overall Survival (It is the time from the date of diagnosis to the date of last news or death). Measurement time: as survival rates one year, three years and five years after the study has concluded.
-Disease-Free Survival (Time from the start of treatment to the date of evidence of disease relapse) Measurement time: as disease-free survival rates one year, three years, and five years after the end of the study.
+    Preoperative: inclusion in ERAS protocols (GENERAL SURGERY SERVICE PROTOCOL).
-Toxicity: (Type of adverse event, severity, causal relationship). Measurement time: baseline, 15 days, week 12, week 24 and 2 months after the end of treatment.
+    Intraoperative: surgical accidents, surgical time, transfusions.
+    Postoperative: complications according to Clavien-Dindo classification, hospital stay, mortality.
+II. Quality of life of patients:
+This will be determined by assessing the effects of treatment related to symptom levels, functional capacity, and general health status. A survey will be applied to patients in both groups at several points in the study (see timeline annex):
+a) Week 0: 15 days after starting supplement intake and before surgical intervention.
+b) Postoperative.
+c) At the end of treatment and surgical discharge.
+The survey collects aspects that allow evaluation of quality of life and comparison intra- and inter-group, as well as intra-individual and inter-individual.
+III. Variables of overall survival, disease-free survival, and toxicity:
+This variable will be evaluated at the same time points as quality of life:
+a) Week 0: 15 days after starting supplement intake.
+b) Postoperative.
+c) Two months after completion of treatment.
-Group A (control): chemotherapy (QT) FOLFOX OR CAPEOX, (intravenous administration) + placebo, in the same way as group B.
+Grupo A (control):
-Group B (experimental): FOLFOX or CAPEOX chemotherapy, (intravenous administration), + Del-Immune V® (DIV). The QT will be administered according to the established scheme and the DIV will be administered 1 capsule (dose) every 12 hours, orally, from 15 days before starting the chemo treatment until 15 days later.
+“Group A (control): will receive the treatment of 2 capsules daily, LOT 425. Each capsule will be administered orally, one every twelve hours, and will be taken continuously from a minimum of 7 days to a maximum of 15 days before the surgical intervention, throughout the entire perioperative period, and for 15 days afterwards.”
-Treatment for both groups will be administered continuously for 29 weeks from patient enrollment.
+Grupo B (experimental):
+“Group B (experimental): will receive 2 capsules daily, LOT 426. The capsules will be taken in the same manner as Group A, with each capsule administered orally, one every twelve hours, and continued under the same schedule.”
 years
-- Patients of any sex, residents in Cuba, aged 18 years or older.
+-Patients of any sex, residents in Cuba, aged 18 years or older.
-- Patients who meet the diagnostic criteria.
-- Patients with a general state of health according to Karnofsky ≥70%.
+-Patients who meet the diagnostic criteria requiring colon or rectal resection.
-- Life expectancy greater than or equal to 3 months.
-- Patients eligible to receive chemotherapy scheme FOLFOX-IV, XELOX or XELIRI.
+-Patients with a general health status according to Karnofsky ≥70%.
-- Patients who have signed the informed consent.
-- Patients who have laboratory values in parameters that do not contraindicate the administration of chemotherapy:
+-Patients who have signed the informed consent.
-- Hemoglobin ≥ 90 g/l
-- Total Leukocyte Count ≥ 3.0 x 109 /L
-- Absolute Neutrophil Count ≥1.5 x 109 /L
-- Platelet count ≥100 x 109 /L
-- Total bilirubin values ≤ 1.5 times the upper limit of the normal range established in the institution.
-- OGRT and OGT values ≤2.5 times the upper limit of the normal range established in the institution.
-- Creatinine values within the normal limits of the institution.
-- Pregnant or lactating patients
+- Pregnant or breastfeeding patients.
-- Patients with known hypersensitivity to 5-Fluoracil, Folinic Acid, Oxaliplatin, Capecitabine or Irinotecan.
-- Patients who are receiving another investigational product.
+-Patients undergoing emergency surgery.
-- Patients with intercurrent decompensated diseases, including: AHT, Diabetes Mellitus, Ischemic Cardiopathy, active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver damage or any other special condition that, at the doctor's discretion, puts their health at risk and your life during the study or your participation in the trial.
-- Patients with brain metastases.
+- Patients currently receiving another investigational product.
-- Patients with mental disorders that could limit adherence to the requirements of the clinical trial and may hinder the collection of information, treatment or follow-up.
+- Patients with brain metastases.
+- Patients with mental disorders that could limit adherence to the clinical trial requirements and hinder data collection, treatment, or follow-up.
--09-10T00:00:00
+-01-20T00:00:00
-/02/13
+/03/09
-/02/13
+/03/09
-Effect of the metabiotic Del-Immune V during chemotherapy treatment in individuals with colon cancer.
+Impact on quality of life and effect on microbiome modulation of the Del-Immune V® formulation in individuals with colon cancer
+A total of 39 patients undergoing resective surgery for colorectal cancer were included, distributed into two groups: Del-Immune V® (Lot 426, n = 22) and Control (Lot 425, n = 17)
+. Demographic Data
+The median age was 68.0 years (IQR: 60.0–75.0) in the Del-Immune V® group and 66.0 years (IQR: 59.0–78.0) in the control group (p = 0.891). No significant differences were observed in sex distribution (female: 63.6% vs. 70.6%, p = 0.736), skin color (white: 77.3% vs. 82.4%, p = 0.709), or baseline body mass index (24.6 vs. 25.8 kg/m², p = 0.867). These results confirm that the groups are comparable in terms of fundamental demographic characteristics.
+. Personal Medical History
+The prevalence of arterial hypertension was similar between groups (36.4% vs. 41.2%, p = 0.759). Type 2 diabetes mellitus was present in 9.1% of the intervention group versus 5.9% of the control group (p = 1.000). Previous or family history of cancer was evenly distributed (50.0% vs. 52.9%, p = 0.853). No significant differences were found in comorbidity burden between groups (all p > 0.05).
+. Baseline Inflammatory and Oncological Biomarkers
+Baseline IL-6 levels were comparable between groups [8.71 pg/mL (IQR: 3.33–22.43) vs. 11.58 pg/mL (IQR: 4.23–39.8), p = 0.456]. Similarly, baseline CRP showed no significant differences [12.82 mg/L (IQR: 5.37–48.12) vs. 15.75 mg/L (IQR: 3.70–40.28), p = 0.734]. Preoperative CEA levels were [4.77 ng/mL (IQR: 2.01–8.88) vs. 3.16 ng/mL (IQR: 1.78–8.87), p = 0.357]. The proportion of patients with elevated biomarkers at baseline was similar between groups (all p > 0.05), indicating balance in inflammatory status and initial tumor burden.
+. Tumor Characteristics
+Most tumors were moderately differentiated in both groups (86.4% vs. 88.2%, p = 0.712). Tumor location was evenly distributed: right colon (50.0% vs. 47.1%), left colon (31.8% vs. 35.3%), transverse (13.6% vs. 11.8%), and rectosigmoid (4.5% vs. 5.9%), p = 0.956. Lymphovascular invasion was present in 45.5% of the Del-Immune V® group versus 41.2% of the control group (p = 0.789). Serosal infiltration was the most frequent in both groups (63.6% vs. 64.7%, p = 0.834).
+. TNM Staging
+Stage distribution was: Stage I (4.5% vs. 0%), Stage II (18.2% vs. 23.5%), Stage III (54.5% vs. 64.7%), and Stage IV (22.7% vs. 0%). A trend toward a higher proportion of Stage IV was observed in the Del-Immune V® group (p = 0.056), representing an important limitation since this group included patients with unresectable metastatic disease who were referred directly to oncology. When stages III–IV were combined, the difference was not significant (77.3% vs. 64.7%, p = 0.389).
+. Surgical Data and Treatment
+All patients were managed under the ERAS protocol (100% in both groups). Length of hospital stay tended to be longer in the Del-Immune V® group [5.0 days (IQR: 3.0–7.0) vs. 3.0 days (IQR: 3.0–5.0), p = 0.070], probably explained by the higher proportion of advanced stages in this group. The reintervention rate was 18.2% in the intervention group versus 0% in the control group (p = 0.056), mainly associated with Stage IV patients requiring additional management. Thirty-day mortality was low in both groups (4.5% vs. 0%, p = 1.000). Adjuvant chemotherapy was administered in 68.2% of the Del-Immune V® group versus 76.5% of the control group (p = 0.736). FOLFOX and XELOX regimens were evenly distributed between groups (all p > 0.05).
+. Conclusion on Baseline Comparability
+In summary, the groups were comparable in most baseline variables evaluated, including age, sex, BMI, comorbidities, preoperative biomarker levels, and tumor characteristics. The only notable difference was the higher proportion of Stage IV patients in the Del-Immune V® group (22.7% vs. 0%, p = 0.056), which should be considered a potential confounding factor in outcome analysis. This difference suggests that the intervention group included patients with more advanced disease, which may have attenuated the observed beneficial effect of the metabolite. Therefore, subsequent analyses should interpret results considering this imbalance, and subgroup analyses stratified by tumor stage are recommended in future studies.
+Levels of Inflammatory and Oncological Biomarkers Pre- and Postoperatively
+BMI and inflammatory biomarkers (IL-6, CRP) as well as the oncological marker (CEA) were evaluated at two time points: baseline (Week 0, preoperative) and final (Week 8, approximately 1 month postoperative). The results of intra-group and inter-group comparisons are presented in Table 2.
+. Body Mass Index (BMI)
+Baseline BMI was comparable between the Del-Immune V® group and the Control group [24.6 kg/m² (IQR: 22.6–27.7) vs. 25.8 kg/m² (IQR: 20.8–28.7), p = 0.867]. At the end of follow-up (Week 8), no significant differences were observed between groups [23.7 kg/m² (IQR: 22.4–26.5) vs. 23.9 kg/m² (IQR: 19.8–26.2), p = 0.923]. The absolute change in BMI (Δ = Final – Baseline) was similar between the Del-Immune V® group [-0.5 kg/m² (IQR: -1.8–0.3)] and the Control group [-0.4 kg/m² (IQR: -1.5–0.6)], with no statistically significant differences (p = 0.789). Intra-group comparisons showed no significant changes from baseline to Week 8 in either group (Del-Immune V®: p = 0.234; Control: p > 0.05). These findings indicate that Del-Immune V® treatment had no significant effect on nutritional status measured by BMI in the early postoperative period.
+. Interleukin-6 (IL-6)
+At the end of follow-up (Week 8), the Del-Immune V® group presented lower IL-6 levels [4.23 pg/mL (IQR: 2.34–8.59)] compared to the Control group [6.23 pg/mL (IQR: 3.22–12.35)], although the difference did not reach statistical significance (p = 0.189). Intra-group analysis showed a significant reduction in IL-6 from baseline to Week 8 in the Del-Immune V® group (p = 0.012), while the Control group showed no significant change (p = 0.570). The magnitude of absolute change (Δ) was greater in the Del-Immune V® group [-3.52 pg/mL (IQR: -8.24–0.45)] versus the Control group [-2.15 pg/mL (IQR: -6.89–1.23)], without significant differences between groups (p = 0.634). These results suggest that Del-Immune V® treatment is associated with a significant reduction in IL-6 levels in the postoperative period, which may reflect modulation of the systemic inflammatory response mediated by the metabolite.
+. C-Reactive Protein (CRP)
+At the end of follow-up (Week 8), both groups showed a marked reduction in CRP levels, with no significant differences between them [3.26 mg/L (IQR: 2.06–6.28) vs. 3.46 mg/L (IQR: 2.27–8.64), p = 0.657]. Intra-group analysis demonstrated a highly significant reduction in CRP from baseline to Week 8 in both groups (Del-Immune V®: p < 0.001; Control: p = 0.001). The magnitude of absolute change (Δ) was greater in the Del-Immune V® group [-8.54 mg/L (IQR: -25.3–(-2.1))] versus the Control group [-5.89 mg/L (IQR: -18.7–(-1.5))], without significant differences between groups (p = 0.423). These findings indicate that resective surgery itself induces a significant reduction in CRP in the postoperative period, reflecting resolution of the tumor-associated inflammatory process. The trend toward greater reduction in the Del-Immune V® group may suggest an additive effect of the metabolite on normalization of this inflammatory marker.
+. Carcinoembryonic Antigen (CEA)
+At the end of follow-up (Week 8), both groups showed a reduction in CEA levels, with no significant differences between them [2.95 ng/mL (IQR: 1.65–5.42) vs. 2.49 ng/mL (IQR: 1.29–3.42), p = 0.312]. Intra-group analysis showed a trend toward reduction of CEA in the Del-Immune V® group (p = 0.076), while the Control group showed no significant change (p = 0.155). The magnitude of absolute change (Δ) was similar between groups [-1.23 ng/mL (IQR: -4.56–0.34) vs. -0.89 ng/mL (IQR: -3.21–0.67), p = 0.567]. These results suggest that surgical resection of the tumor is associated with a reduction in CEA levels in the early postoperative period, as expected. The trend toward greater reduction in the Del-Immune V® group may indicate a beneficial effect of the metabolite on residual tumor burden or associated inflammation.
+These findings support the hypothesis that Del-Immune V® may modulate the perioperative inflammatory response in patients undergoing resective surgery for colorectal cancer, particularly through the reduction of IL-6, a key marker of systemic inflammation and prognosis in this population.
+. Magnitude of Percentage Change in Biomarkers
+The magnitude of change in inflammatory and oncological biomarkers was evaluated by calculating the percentage change (Δ%) between baseline values (Week 0) and final values (Week 8). Additionally, the proportion of patients who achieved normalization of each biomarker (values within the reference range at the end of follow-up) was analyzed. Results are presented in Table 3.
+. Percentage Change in Interleukin-6 (IL-6)
+The percentage change in IL-6 levels showed a greater reduction in the Del-Immune V® group [-45.2% (IQR: -68.5 to -12.3)] compared to the Control group [-28.7% (IQR: -55.4 to 8.9)], without reaching statistical significance (p = 0.234). These results indicate that although both groups experienced a decrease in IL-6 levels during the postoperative period, the magnitude of reduction was approximately 1.6 times greater in the group receiving the metabolite. It is noteworthy that the interquartile range of the control group included positive values (up to 8.9%), suggesting that some patients in this group experienced an increase in IL-6 levels rather than a reduction.
+. Percentage Change in C-Reactive Protein (CRP)
+The percentage change in CRP showed a more pronounced reduction in the Del-Immune V® group [-62.8% (IQR: -85.2 to -35.6)] versus the Control group [-48.3% (IQR: -72.1 to -18.9)], with a difference that did not reach statistical significance (p = 0.189). The magnitude of CRP reduction exceeded 60% in the intervention group, reflecting faster normalization of this acute inflammatory marker. As with IL-6, the interquartile range of the control group showed greater variability, with some patients presenting less marked reductions.
+. Percentage Change in Carcinoembryonic Antigen (CEA)
+The percentage change in CEA was similar between the Del-Immune V® group [-32.5% (IQR: -58.9 to 12.4)] and the Control group [-25.6% (IQR: -48.7 to 18.3)], with no statistically significant differences (p = 0.445). Both groups showed moderate reductions in CEA levels, consistent with surgical resection of the primary tumor. It is notable that the interquartile ranges of both groups included positive values, indicating that a subset of patients experienced an increase in CEA levels during follow-up, which may reflect residual or progressive disease.
+. Normalization Rates of Biomarkers
+    IL-6: Normalization (<5 pg/mL at Week 8) was observed in 14 of 22 patients (63.6%) in the Del-Immune V® group versus 8 of 17 patients (47.1%) in the Control group, without significant differences (p = 0.298). Although not statistically significant, the normalization rate was 1.36 times higher in the intervention group.
+    CRP: Normalization (<5 mg/L at Week 8) was achieved in 18 of 22 patients (81.8%) in the Del-Immune V® group versus 12 of 17 patients (70.6%) in the Control group (p = 0.489). This biomarker showed the highest normalization rates in both groups, consistent with its role as an acute inflammatory marker that tends to normalize after surgical resolution.
+    CEA: Normalization (<4.7 ng/mL at Week 8) was observed in 15 of 22 patients (68.2%) in the Del-Immune V® group versus 11 of 17 patients (64.7%) in the Control group (p = 0.812). Rates were similar between groups, reflecting that this oncological marker responds primarily to tumor resection rather than metabolite treatment.
+These findings are consistent with the hypothesis that Del-Immune V® may modulate the perioperative inflammatory response, although larger studies are required to confirm these effects with greater statistical precision.
+. Perioperative Clinical Outcomes
+Perioperative clinical outcomes were evaluated by recording complications, reinterventions, mortality, length of hospital stay, recovery of intestinal transit, readmissions, and disease status at follow-up. Results are presented in Table 4.
+. Total Complications
+Total complications occurred in 5 of 22 patients (22.7%) in the Del-Immune V® group versus 1 of 17 patients (5.9%) in the Control group, with no statistically significant differences (p = 0.206). Although the complication rate was approximately 3.9 times higher in the intervention group, the low number of events limits the ability to detect significant differences. Infectious complications occurred in 3 patients (13.6%) in the Del-Immune V® group versus 1 patient (5.9%) in the Control group (p = 0.634). Surgical complications (dehiscence, fistula, hemorrhage) occurred in 2 patients (9.1%) in the intervention group versus none in the control group (p = 0.487).
+. Reintervention and Mortality
+The reintervention rate was 4 patients (18.2%) in the Del-Immune V® group versus 0 patients (0%) in the Control group, with a trend toward statistical significance (p = 0.056). Most reinterventions in the Del-Immune V® group corresponded to Stage IV patients requiring additional management of metastatic disease or complications related to advanced disease. Thirty-day mortality was 1 patient (4.5%) in the Del-Immune V® group versus 0 patients (0%) in the Control group (p = 1.000). Six-month mortality was 2 patients (9.1%) in the intervention group versus 0 patients (0%) in the Control group (p = 0.487). Causes of death were related to progression of metastatic disease in both cases.
+. Postoperative Recovery
+Length of hospital stay was longer in the Del-Immune V® group [5.0 days (IQR: 3.0–7.0)] compared to the Control group [3.0 days (IQR: 3.0–5.0)], with a trend toward statistical significance (p = 0.070). This difference may be partially explained by the higher proportion of Stage IV patients in the intervention group, who required longer hospitalizations for advanced disease management. Recovery of intestinal transit, measured as time to first bowel movement, was 3.0 days (IQR: 2.0–4.0) in the Del-Immune V® group versus 2.0 days (IQR: 2.0–3.0) in the Control group (p = 0.123). Although not statistically significant, a trend toward slower recovery was observed in the intervention group.
+. Readmission and Follow-up
+Thirty-day readmissions occurred in 2 patients (9.1%) in the Del-Immune V® group versus 1 patient (5.9%) in the Control group (p = 1.000). Ninety-day readmissions were 3 patients (13.6%) versus 1 patient (5.9%), respectively (p = 0.634). None of these differences reached statistical significance. Completion of adjuvant chemotherapy was similar between groups: 12 of 15 patients (80.0%) in the Del-Immune V® group versus 11 of 13 patients (84.6%) in the Control group completed the proposed regimen (p = 1.000). This suggests that metabolite treatment did not negatively affect tolerance to adjuvant chemotherapy.
+. Disease Status at Follow-up (February 2026)
+At the time of the last follow-up (February 2026), disease was controlled in 14 patients (63.6%) in the Del-Immune V® group versus 13 patients (76.5%) in the Control group (p = 0.389). Disease progression occurred in 4 patients (18.2%) in the intervention group versus 1 patient (5.9%) in the Control group (p = 0.356). Recurrences were observed in 2 patients (9.1%) in the Del-Immune V® group versus 2 patients (11.8%) in the Control group (p = 1.000), with no significant differences between groups. Deaths at follow-up were 2 patients (9.1%) in the intervention group versus 0 patients (0%) in the Control group (p = 0.487).
+Conclusion: These findings must be interpreted considering the important limitation of tumor stage imbalance between groups, with a higher proportion of Stage IV patients in the Del-Immune V® group (22.7% vs. 0%, p = 0.056), which represents a confounding factor that may have attenuated the potential beneficial effects of the metabolite.
+. Correlation Between Biomarkers and Clinical Outcomes
+The association between inflammatory biomarkers (IL-6, CRP) and the oncological biomarker (CEA), measured at Week 8 postoperatively, as well as their changes from baseline (Δ), was evaluated in relation to various relevant clinical outcomes. Spearman correlation coefficients and their statistical significance values are presented in Table 5.
+. Length of Hospital Stay
+Length of hospital stay did not show statistically significant correlations with any of the biomarkers evaluated at Week 8. However, a trend toward a moderate positive correlation was observed with CRP at Week 8 (r = 0.289, p = 0.074), suggesting that patients with higher CRP levels at the end of follow-up may require longer hospital stays. IL-6 at Week 8 showed a weak positive correlation (r = 0.234, p = 0.152), while CEA at Week 8 presented the lowest correlation (r = 0.156, p = 0.345). Changes in biomarkers from baseline (Δ IL-6, Δ CRP, Δ CEA) were not significantly associated with hospital stay (all p > 0.05).
+. Postoperative Complications
+The presence of postoperative complications (Yes/No) showed a trend toward positive correlation with IL-6 levels at Week 8 (r = 0.312, p = 0.054), indicating that patients with higher levels of this inflammatory marker at the end of follow-up may have a greater likelihood of experiencing complications. CRP at Week 8 also showed a moderate positive correlation, though not significant (r = 0.278, p = 0.087). CEA at Week 8 presented a weaker correlation (r = 0.189, p = 0.248). Changes in biomarkers from baseline showed moderate negative correlations with complications (Δ IL-6: r = -0.267, p = 0.099; Δ CRP: r = -0.245, p = 0.134), suggesting that patients with greater reductions in inflammatory markers may have lower risk of complications, although these associations did not reach statistical significance.
+. Surgical Reintervention
+The need for surgical reintervention did not show significant correlations with any biomarker evaluated. A trend toward positive correlation was observed with IL-6 at Week 8 (r = 0.289, p = 0.075), consistent with the finding of a higher reintervention rate in the Del-Immune V® group observed in Table 4, likely related to the higher proportion of advanced-stage patients in this group. Changes in biomarkers (Δ) were not significantly associated with reintervention (all p > 0.05).
+. CEA Levels at Week 8
+CEA levels at Week 8 showed trends toward positive correlation with inflammatory markers IL-6 at Week 8 (r = 0.298, p = 0.066) and CRP at Week 8 (r = 0.267, p = 0.101). This suggests that patients with greater systemic inflammation at the end of follow-up may have higher levels of the tumor marker, possibly reflecting residual disease or tumor-associated inflammatory response. Changes in inflammatory biomarkers showed moderate negative correlations with CEA at Week 8 (Δ IL-6: r = -0.245, p = 0.134; Δ CRP: r = -0.223, p = 0.172), indicating that greater reductions in inflammation are associated with lower postoperative CEA levels.
+General Safety Profile
+The safety profile of Del-Immune V® treatment was evaluated through systematic recording of adverse and beneficial effects reported by patients during the follow-up period. Two groups were compared: Del-Immune V® (Lot 426, n = 22) and Placebo (Lot 425, n = 17).
+No adverse effects directly related to capsule consumption were reported in either group (0% in both), suggesting good tolerability of the product.
+No cases of bronchitis, cystitis, dental pain, dizziness and nausea, general malaise, genital herpes, recurrent infection, prostate inflammation, oral ulcer, muscle discomfort, nasal obstruction, orthopedic pain, palpitations, rhinitis, sore throat, tracheitis, vaginal dryness, or vagal crises were recorded in either group.
+No cases of bronchitis, cystitis, dental pain, dizziness and nausea, general malaise, genital herpes, recurrent infection, prostate inflammation, oral ulcer, muscle discomfort, nasal obstruction, orthopedic pain, palpitations, rhinitis, sore throat, tracheitis, vaginal dryness, or vagal crises were recorded in either group.
+General Incidence:
+A total of 18 patients (81.8%) in the Del-Immune V® group reported at least one beneficial effect, compared to 15 patients (88.2%) in the Placebo group, with no statistically significant differences (p = 0.701).
+The total number of beneficial events was 49 in the Del-Immune V® group versus 46 in the Placebo group (p = 0.678). The mean number of beneficial events per patient was 2.23 in Del-Immune V® versus 2.71 in Placebo (p = 0.456).
+Clinical Implications
+These findings have the following implications:
+    Del-Immune V® is safe and well tolerated, with an adverse effect profile comparable to placebo.
+    Mild gastrointestinal effects are expected with a metabolite and do not require discontinuation of treatment.
+    The potential effect on anxiety warrants further investigation in studies specifically designed to evaluate mental health outcomes.
+    The absence of serious adverse effects supports the continuation of clinical development of this product.
+    Continuous safety monitoring should be maintained in subsequent phases of clinical development.
+The study included 39 patients with colorectal cancer undergoing resective surgery, distributed into two groups (Del-Immune V® and Control) with comparable baseline characteristics, except for a higher proportion of Stage IV in the intervention group (22.7% vs. 0%, p = 0.056). During follow-up, a significant reduction in interleukin-6 was observed in the Del-Immune V® group (p = 0.012), while C-reactive protein decreased significantly in both groups (Del-Immune V®: p < 0.001; Control: p = 0.001), with a trend toward greater magnitude in the intervention group. Carcinoembryonic antigen showed a moderate reduction, with a favorable trend in Del-Immune V® (p = 0.076).
+Regarding clinical outcomes, complications (22.7% vs. 5.9%), reintervention (18.2% vs. 0%, p = 0.056), and hospital stay (5.0 vs. 3.0 days, p = 0.070) were more frequent in the intervention group, likely due to the higher burden of advanced disease, although without statistically significant differences in most cases.
+In conclusion, the findings suggest that Del-Immune V® may modulate the perioperative inflammatory response, particularly through the reduction of IL-6. However, the imbalance in staging limits interpretation, and confirmation of these results in studies with larger sample sizes is recommended.

Revisión de 9 Marzo 2026 - 11:50am

IVD in colon cancer

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Impact on quality of life and effect on microbiome modulation of the Del-Immune V® formulation in individuals with colon cancer

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Stellar Biotics

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Gissel

Last name:

Garcia Menendez

Medical Specialty :

Biochemistry, Master in Virology

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal address:

San Lazaro 701 corner Belascoain, Centro Habana

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78761632

+53-52706385

Email address:

gisselgarcia@infomed.sld.cu

gisselgarcia2805@gmail.com

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not Applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

16/09/2024

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Colon Cancer

Health condition(s) code:

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Intestinal Diseases

Gastrointestinal Diseases

Digestive System Diseases

Intervention(s):

Grupo A (control): “Group A (control): will receive the treatment of 2 capsules daily, LOT 425. Each capsule will be administered orally, one every twelve hours, and will be taken continuously from a minimum of 7 days to a maximum of 15 days before the surgical intervention, throughout the entire perioperative period, and for 15 days afterwards.” Grupo B (experimental): “Group B (experimental): will receive 2 capsules daily, LOT 426. The capsules will be taken in the same manner as Group A, with each capsule administered orally, one every twelve hours, and continued under the same schedule.”

Intervention code:

Dietary Supplements

Placebos

Administration, Oral

Administration, Intravenous

Intervention keyword:

Metabiotic Del-Immune V

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Levels of inflammatory biomarkers. IL-6 (measured in pg/mL), C-reactive protein (measured in mg/L), tumor marker CEA (measured in ng/mL). Measurement time: baseline, 8 weeks.

Key secondary outcomes:

I. Perioperative evolution: Preoperative: inclusion in ERAS protocols (GENERAL SURGERY SERVICE PROTOCOL). Intraoperative: surgical accidents, surgical time, transfusions. Postoperative: complications according to Clavien-Dindo classification, hospital stay, mortality. II. Quality of life of patients: This will be determined by assessing the effects of treatment related to symptom levels, functional capacity, and general health status. A survey will be applied to patients in both groups at several points in the study (see timeline annex): a) Week 0: 15 days after starting supplement intake and before surgical intervention. b) Postoperative. c) At the end of treatment and surgical discharge. The survey collects aspects that allow evaluation of quality of life and comparison intra- and inter-group, as well as intra-individual and inter-individual. III. Variables of overall survival, disease-free survival, and toxicity: This variable will be evaluated at the same time points as quality of life: a) Week 0: 15 days after starting supplement intake. b) Postoperative. c) Two months after completion of treatment.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

None

Inclusion criteria:

1-Patients of any sex, residents in Cuba, aged 18 years or older. 2-Patients who meet the diagnostic criteria requiring colon or rectal resection. 3-Patients with a general health status according to Karnofsky ≥70%. 4-Patients who have signed the informed consent.

Exclusion criteria:

1 - Pregnant or breastfeeding patients. 2-Patients undergoing emergency surgery. 3- Patients currently receiving another investigational product. 4- Patients with brain metastases. 5- Patients with mental disorders that could limit adherence to the clinical trial requirements and hinder data collection, treatment, or follow-up.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Gissel

Last Name:

Garcia Menendez

Specialty:

Biochemistry, Master in Virology

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal Address:

San Lazaro 701 corner Belascoain, Centro Habana

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78761632

Email :

gisselgarcia@infomed.sld.cu

gisselgarcia280@gmail.com

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Gissel

Last Name:

Garcia Menendez

Specialty:

Biochemistry, Master in Virology

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal Address:

San Lazaro 701 corner Belascoain, Centro Habana

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78761632

Email :

gisselgarcia@infomed.sld.cu

gisselgarcia2805@gmail.com

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Hermanos Ameijeiras Surgical Clinical Hospital (HHA)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

11/05/2022

Postal address of Ethic Committee :

San Lazaro 701 corner Belascoain, Centro Habana, ZC 10400. Havana, Cuba

Telephone:

+53-78761000

Correo electrónico:

hha@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

Study completion date:

20/01/2026

Results Study

Section to complete the data related to the summarized results.

Participant flow:

A total of 39 patients undergoing resective surgery for colorectal cancer were included, distributed into two groups: Del-Immune V® (Lot 426, n = 22) and Control (Lot 425, n = 17)

Baseline characteristics:

1. Demographic Data The median age was 68.0 years (IQR: 60.0–75.0) in the Del-Immune V® group and 66.0 years (IQR: 59.0–78.0) in the control group (p = 0.891). No significant differences were observed in sex distribution (female: 63.6% vs. 70.6%, p = 0.736), skin color (white: 77.3% vs. 82.4%, p = 0.709), or baseline body mass index (24.6 vs. 25.8 kg/m², p = 0.867). These results confirm that the groups are comparable in terms of fundamental demographic characteristics. 2. Personal Medical History The prevalence of arterial hypertension was similar between groups (36.4% vs. 41.2%, p = 0.759). Type 2 diabetes mellitus was present in 9.1% of the intervention group versus 5.9% of the control group (p = 1.000). Previous or family history of cancer was evenly distributed (50.0% vs. 52.9%, p = 0.853). No significant differences were found in comorbidity burden between groups (all p > 0.05). 3. Baseline Inflammatory and Oncological Biomarkers Baseline IL-6 levels were comparable between groups [8.71 pg/mL (IQR: 3.33–22.43) vs. 11.58 pg/mL (IQR: 4.23–39.8), p = 0.456]. Similarly, baseline CRP showed no significant differences [12.82 mg/L (IQR: 5.37–48.12) vs. 15.75 mg/L (IQR: 3.70–40.28), p = 0.734]. Preoperative CEA levels were [4.77 ng/mL (IQR: 2.01–8.88) vs. 3.16 ng/mL (IQR: 1.78–8.87), p = 0.357]. The proportion of patients with elevated biomarkers at baseline was similar between groups (all p > 0.05), indicating balance in inflammatory status and initial tumor burden. 4. Tumor Characteristics Most tumors were moderately differentiated in both groups (86.4% vs. 88.2%, p = 0.712). Tumor location was evenly distributed: right colon (50.0% vs. 47.1%), left colon (31.8% vs. 35.3%), transverse (13.6% vs. 11.8%), and rectosigmoid (4.5% vs. 5.9%), p = 0.956. Lymphovascular invasion was present in 45.5% of the Del-Immune V® group versus 41.2% of the control group (p = 0.789). Serosal infiltration was the most frequent in both groups (63.6% vs. 64.7%, p = 0.834). 5. TNM Staging Stage distribution was: Stage I (4.5% vs. 0%), Stage II (18.2% vs. 23.5%), Stage III (54.5% vs. 64.7%), and Stage IV (22.7% vs. 0%). A trend toward a higher proportion of Stage IV was observed in the Del-Immune V® group (p = 0.056), representing an important limitation since this group included patients with unresectable metastatic disease who were referred directly to oncology. When stages III–IV were combined, the difference was not significant (77.3% vs. 64.7%, p = 0.389). 6. Surgical Data and Treatment All patients were managed under the ERAS protocol (100% in both groups). Length of hospital stay tended to be longer in the Del-Immune V® group [5.0 days (IQR: 3.0–7.0) vs. 3.0 days (IQR: 3.0–5.0), p = 0.070], probably explained by the higher proportion of advanced stages in this group. The reintervention rate was 18.2% in the intervention group versus 0% in the control group (p = 0.056), mainly associated with Stage IV patients requiring additional management. Thirty-day mortality was low in both groups (4.5% vs. 0%, p = 1.000). Adjuvant chemotherapy was administered in 68.2% of the Del-Immune V® group versus 76.5% of the control group (p = 0.736). FOLFOX and XELOX regimens were evenly distributed between groups (all p > 0.05). 7. Conclusion on Baseline Comparability In summary, the groups were comparable in most baseline variables evaluated, including age, sex, BMI, comorbidities, preoperative biomarker levels, and tumor characteristics. The only notable difference was the higher proportion of Stage IV patients in the Del-Immune V® group (22.7% vs. 0%, p = 0.056), which should be considered a potential confounding factor in outcome analysis. This difference suggests that the intervention group included patients with more advanced disease, which may have attenuated the observed beneficial effect of the metabolite. Therefore, subsequent analyses should interpret results considering this imbalance, and subgroup analyses stratified by tumor stage are recommended in future studies.

Outcome measures:

Levels of Inflammatory and Oncological Biomarkers Pre- and Postoperatively BMI and inflammatory biomarkers (IL-6, CRP) as well as the oncological marker (CEA) were evaluated at two time points: baseline (Week 0, preoperative) and final (Week 8, approximately 1 month postoperative). The results of intra-group and inter-group comparisons are presented in Table 2. 1. Body Mass Index (BMI) Baseline BMI was comparable between the Del-Immune V® group and the Control group [24.6 kg/m² (IQR: 22.6–27.7) vs. 25.8 kg/m² (IQR: 20.8–28.7), p = 0.867]. At the end of follow-up (Week 8), no significant differences were observed between groups [23.7 kg/m² (IQR: 22.4–26.5) vs. 23.9 kg/m² (IQR: 19.8–26.2), p = 0.923]. The absolute change in BMI (Δ = Final – Baseline) was similar between the Del-Immune V® group [-0.5 kg/m² (IQR: -1.8–0.3)] and the Control group [-0.4 kg/m² (IQR: -1.5–0.6)], with no statistically significant differences (p = 0.789). Intra-group comparisons showed no significant changes from baseline to Week 8 in either group (Del-Immune V®: p = 0.234; Control: p > 0.05). These findings indicate that Del-Immune V® treatment had no significant effect on nutritional status measured by BMI in the early postoperative period. 2. Interleukin-6 (IL-6) At the end of follow-up (Week 8), the Del-Immune V® group presented lower IL-6 levels [4.23 pg/mL (IQR: 2.34–8.59)] compared to the Control group [6.23 pg/mL (IQR: 3.22–12.35)], although the difference did not reach statistical significance (p = 0.189). Intra-group analysis showed a significant reduction in IL-6 from baseline to Week 8 in the Del-Immune V® group (p = 0.012), while the Control group showed no significant change (p = 0.570). The magnitude of absolute change (Δ) was greater in the Del-Immune V® group [-3.52 pg/mL (IQR: -8.24–0.45)] versus the Control group [-2.15 pg/mL (IQR: -6.89–1.23)], without significant differences between groups (p = 0.634). These results suggest that Del-Immune V® treatment is associated with a significant reduction in IL-6 levels in the postoperative period, which may reflect modulation of the systemic inflammatory response mediated by the metabolite. 3. C-Reactive Protein (CRP) At the end of follow-up (Week 8), both groups showed a marked reduction in CRP levels, with no significant differences between them [3.26 mg/L (IQR: 2.06–6.28) vs. 3.46 mg/L (IQR: 2.27–8.64), p = 0.657]. Intra-group analysis demonstrated a highly significant reduction in CRP from baseline to Week 8 in both groups (Del-Immune V®: p < 0.001; Control: p = 0.001). The magnitude of absolute change (Δ) was greater in the Del-Immune V® group [-8.54 mg/L (IQR: -25.3–(-2.1))] versus the Control group [-5.89 mg/L (IQR: -18.7–(-1.5))], without significant differences between groups (p = 0.423). These findings indicate that resective surgery itself induces a significant reduction in CRP in the postoperative period, reflecting resolution of the tumor-associated inflammatory process. The trend toward greater reduction in the Del-Immune V® group may suggest an additive effect of the metabolite on normalization of this inflammatory marker. 4. Carcinoembryonic Antigen (CEA) At the end of follow-up (Week 8), both groups showed a reduction in CEA levels, with no significant differences between them [2.95 ng/mL (IQR: 1.65–5.42) vs. 2.49 ng/mL (IQR: 1.29–3.42), p = 0.312]. Intra-group analysis showed a trend toward reduction of CEA in the Del-Immune V® group (p = 0.076), while the Control group showed no significant change (p = 0.155). The magnitude of absolute change (Δ) was similar between groups [-1.23 ng/mL (IQR: -4.56–0.34) vs. -0.89 ng/mL (IQR: -3.21–0.67), p = 0.567]. These results suggest that surgical resection of the tumor is associated with a reduction in CEA levels in the early postoperative period, as expected. The trend toward greater reduction in the Del-Immune V® group may indicate a beneficial effect of the metabolite on residual tumor burden or associated inflammation. These findings support the hypothesis that Del-Immune V® may modulate the perioperative inflammatory response in patients undergoing resective surgery for colorectal cancer, particularly through the reduction of IL-6, a key marker of systemic inflammation and prognosis in this population. 3. Magnitude of Percentage Change in Biomarkers The magnitude of change in inflammatory and oncological biomarkers was evaluated by calculating the percentage change (Δ%) between baseline values (Week 0) and final values (Week 8). Additionally, the proportion of patients who achieved normalization of each biomarker (values within the reference range at the end of follow-up) was analyzed. Results are presented in Table 3. 1. Percentage Change in Interleukin-6 (IL-6) The percentage change in IL-6 levels showed a greater reduction in the Del-Immune V® group [-45.2% (IQR: -68.5 to -12.3)] compared to the Control group [-28.7% (IQR: -55.4 to 8.9)], without reaching statistical significance (p = 0.234). These results indicate that although both groups experienced a decrease in IL-6 levels during the postoperative period, the magnitude of reduction was approximately 1.6 times greater in the group receiving the metabolite. It is noteworthy that the interquartile range of the control group included positive values (up to 8.9%), suggesting that some patients in this group experienced an increase in IL-6 levels rather than a reduction. 2. Percentage Change in C-Reactive Protein (CRP) The percentage change in CRP showed a more pronounced reduction in the Del-Immune V® group [-62.8% (IQR: -85.2 to -35.6)] versus the Control group [-48.3% (IQR: -72.1 to -18.9)], with a difference that did not reach statistical significance (p = 0.189). The magnitude of CRP reduction exceeded 60% in the intervention group, reflecting faster normalization of this acute inflammatory marker. As with IL-6, the interquartile range of the control group showed greater variability, with some patients presenting less marked reductions. 3. Percentage Change in Carcinoembryonic Antigen (CEA) The percentage change in CEA was similar between the Del-Immune V® group [-32.5% (IQR: -58.9 to 12.4)] and the Control group [-25.6% (IQR: -48.7 to 18.3)], with no statistically significant differences (p = 0.445). Both groups showed moderate reductions in CEA levels, consistent with surgical resection of the primary tumor. It is notable that the interquartile ranges of both groups included positive values, indicating that a subset of patients experienced an increase in CEA levels during follow-up, which may reflect residual or progressive disease. 4. Normalization Rates of Biomarkers IL-6: Normalization (<5 pg/mL at Week 8) was observed in 14 of 22 patients (63.6%) in the Del-Immune V® group versus 8 of 17 patients (47.1%) in the Control group, without significant differences (p = 0.298). Although not statistically significant, the normalization rate was 1.36 times higher in the intervention group. CRP: Normalization (<5 mg/L at Week 8) was achieved in 18 of 22 patients (81.8%) in the Del-Immune V® group versus 12 of 17 patients (70.6%) in the Control group (p = 0.489). This biomarker showed the highest normalization rates in both groups, consistent with its role as an acute inflammatory marker that tends to normalize after surgical resolution. CEA: Normalization (<4.7 ng/mL at Week 8) was observed in 15 of 22 patients (68.2%) in the Del-Immune V® group versus 11 of 17 patients (64.7%) in the Control group (p = 0.812). Rates were similar between groups, reflecting that this oncological marker responds primarily to tumor resection rather than metabolite treatment. These findings are consistent with the hypothesis that Del-Immune V® may modulate the perioperative inflammatory response, although larger studies are required to confirm these effects with greater statistical precision. 4. Perioperative Clinical Outcomes Perioperative clinical outcomes were evaluated by recording complications, reinterventions, mortality, length of hospital stay, recovery of intestinal transit, readmissions, and disease status at follow-up. Results are presented in Table 4. 1. Total Complications Total complications occurred in 5 of 22 patients (22.7%) in the Del-Immune V® group versus 1 of 17 patients (5.9%) in the Control group, with no statistically significant differences (p = 0.206). Although the complication rate was approximately 3.9 times higher in the intervention group, the low number of events limits the ability to detect significant differences. Infectious complications occurred in 3 patients (13.6%) in the Del-Immune V® group versus 1 patient (5.9%) in the Control group (p = 0.634). Surgical complications (dehiscence, fistula, hemorrhage) occurred in 2 patients (9.1%) in the intervention group versus none in the control group (p = 0.487). 2. Reintervention and Mortality The reintervention rate was 4 patients (18.2%) in the Del-Immune V® group versus 0 patients (0%) in the Control group, with a trend toward statistical significance (p = 0.056). Most reinterventions in the Del-Immune V® group corresponded to Stage IV patients requiring additional management of metastatic disease or complications related to advanced disease. Thirty-day mortality was 1 patient (4.5%) in the Del-Immune V® group versus 0 patients (0%) in the Control group (p = 1.000). Six-month mortality was 2 patients (9.1%) in the intervention group versus 0 patients (0%) in the Control group (p = 0.487). Causes of death were related to progression of metastatic disease in both cases. 3. Postoperative Recovery Length of hospital stay was longer in the Del-Immune V® group [5.0 days (IQR: 3.0–7.0)] compared to the Control group [3.0 days (IQR: 3.0–5.0)], with a trend toward statistical significance (p = 0.070). This difference may be partially explained by the higher proportion of Stage IV patients in the intervention group, who required longer hospitalizations for advanced disease management. Recovery of intestinal transit, measured as time to first bowel movement, was 3.0 days (IQR: 2.0–4.0) in the Del-Immune V® group versus 2.0 days (IQR: 2.0–3.0) in the Control group (p = 0.123). Although not statistically significant, a trend toward slower recovery was observed in the intervention group. 4. Readmission and Follow-up Thirty-day readmissions occurred in 2 patients (9.1%) in the Del-Immune V® group versus 1 patient (5.9%) in the Control group (p = 1.000). Ninety-day readmissions were 3 patients (13.6%) versus 1 patient (5.9%), respectively (p = 0.634). None of these differences reached statistical significance. Completion of adjuvant chemotherapy was similar between groups: 12 of 15 patients (80.0%) in the Del-Immune V® group versus 11 of 13 patients (84.6%) in the Control group completed the proposed regimen (p = 1.000). This suggests that metabolite treatment did not negatively affect tolerance to adjuvant chemotherapy. 5. Disease Status at Follow-up (February 2026) At the time of the last follow-up (February 2026), disease was controlled in 14 patients (63.6%) in the Del-Immune V® group versus 13 patients (76.5%) in the Control group (p = 0.389). Disease progression occurred in 4 patients (18.2%) in the intervention group versus 1 patient (5.9%) in the Control group (p = 0.356). Recurrences were observed in 2 patients (9.1%) in the Del-Immune V® group versus 2 patients (11.8%) in the Control group (p = 1.000), with no significant differences between groups. Deaths at follow-up were 2 patients (9.1%) in the intervention group versus 0 patients (0%) in the Control group (p = 0.487). Conclusion: These findings must be interpreted considering the important limitation of tumor stage imbalance between groups, with a higher proportion of Stage IV patients in the Del-Immune V® group (22.7% vs. 0%, p = 0.056), which represents a confounding factor that may have attenuated the potential beneficial effects of the metabolite. 5. Correlation Between Biomarkers and Clinical Outcomes The association between inflammatory biomarkers (IL-6, CRP) and the oncological biomarker (CEA), measured at Week 8 postoperatively, as well as their changes from baseline (Δ), was evaluated in relation to various relevant clinical outcomes. Spearman correlation coefficients and their statistical significance values are presented in Table 5. 1. Length of Hospital Stay Length of hospital stay did not show statistically significant correlations with any of the biomarkers evaluated at Week 8. However, a trend toward a moderate positive correlation was observed with CRP at Week 8 (r = 0.289, p = 0.074), suggesting that patients with higher CRP levels at the end of follow-up may require longer hospital stays. IL-6 at Week 8 showed a weak positive correlation (r = 0.234, p = 0.152), while CEA at Week 8 presented the lowest correlation (r = 0.156, p = 0.345). Changes in biomarkers from baseline (Δ IL-6, Δ CRP, Δ CEA) were not significantly associated with hospital stay (all p > 0.05). 2. Postoperative Complications The presence of postoperative complications (Yes/No) showed a trend toward positive correlation with IL-6 levels at Week 8 (r = 0.312, p = 0.054), indicating that patients with higher levels of this inflammatory marker at the end of follow-up may have a greater likelihood of experiencing complications. CRP at Week 8 also showed a moderate positive correlation, though not significant (r = 0.278, p = 0.087). CEA at Week 8 presented a weaker correlation (r = 0.189, p = 0.248). Changes in biomarkers from baseline showed moderate negative correlations with complications (Δ IL-6: r = -0.267, p = 0.099; Δ CRP: r = -0.245, p = 0.134), suggesting that patients with greater reductions in inflammatory markers may have lower risk of complications, although these associations did not reach statistical significance. 3. Surgical Reintervention The need for surgical reintervention did not show significant correlations with any biomarker evaluated. A trend toward positive correlation was observed with IL-6 at Week 8 (r = 0.289, p = 0.075), consistent with the finding of a higher reintervention rate in the Del-Immune V® group observed in Table 4, likely related to the higher proportion of advanced-stage patients in this group. Changes in biomarkers (Δ) were not significantly associated with reintervention (all p > 0.05). 4. CEA Levels at Week 8 CEA levels at Week 8 showed trends toward positive correlation with inflammatory markers IL-6 at Week 8 (r = 0.298, p = 0.066) and CRP at Week 8 (r = 0.267, p = 0.101). This suggests that patients with greater systemic inflammation at the end of follow-up may have higher levels of the tumor marker, possibly reflecting residual disease or tumor-associated inflammatory response. Changes in inflammatory biomarkers showed moderate negative correlations with CEA at Week 8 (Δ IL-6: r = -0.245, p = 0.134; Δ CRP: r = -0.223, p = 0.172), indicating that greater reductions in inflammation are associated with lower postoperative CEA levels.

Adverse events:

General Safety Profile The safety profile of Del-Immune V® treatment was evaluated through systematic recording of adverse and beneficial effects reported by patients during the follow-up period. Two groups were compared: Del-Immune V® (Lot 426, n = 22) and Placebo (Lot 425, n = 17). No adverse effects directly related to capsule consumption were reported in either group (0% in both), suggesting good tolerability of the product. No cases of bronchitis, cystitis, dental pain, dizziness and nausea, general malaise, genital herpes, recurrent infection, prostate inflammation, oral ulcer, muscle discomfort, nasal obstruction, orthopedic pain, palpitations, rhinitis, sore throat, tracheitis, vaginal dryness, or vagal crises were recorded in either group. No cases of bronchitis, cystitis, dental pain, dizziness and nausea, general malaise, genital herpes, recurrent infection, prostate inflammation, oral ulcer, muscle discomfort, nasal obstruction, orthopedic pain, palpitations, rhinitis, sore throat, tracheitis, vaginal dryness, or vagal crises were recorded in either group. General Incidence: A total of 18 patients (81.8%) in the Del-Immune V® group reported at least one beneficial effect, compared to 15 patients (88.2%) in the Placebo group, with no statistically significant differences (p = 0.701). The total number of beneficial events was 49 in the Del-Immune V® group versus 46 in the Placebo group (p = 0.678). The mean number of beneficial events per patient was 2.23 in Del-Immune V® versus 2.71 in Placebo (p = 0.456). Clinical Implications These findings have the following implications: Del-Immune V® is safe and well tolerated, with an adverse effect profile comparable to placebo. Mild gastrointestinal effects are expected with a metabolite and do not require discontinuation of treatment. The potential effect on anxiety warrants further investigation in studies specifically designed to evaluate mental health outcomes. The absence of serious adverse effects supports the continuation of clinical development of this product. Continuous safety monitoring should be maintained in subsequent phases of clinical development.

Summary study:

The study included 39 patients with colorectal cancer undergoing resective surgery, distributed into two groups (Del-Immune V® and Control) with comparable baseline characteristics, except for a higher proportion of Stage IV in the intervention group (22.7% vs. 0%, p = 0.056). During follow-up, a significant reduction in interleukin-6 was observed in the Del-Immune V® group (p = 0.012), while C-reactive protein decreased significantly in both groups (Del-Immune V®: p < 0.001; Control: p = 0.001), with a trend toward greater magnitude in the intervention group. Carcinoembryonic antigen showed a moderate reduction, with a favorable trend in Del-Immune V® (p = 0.076). Regarding clinical outcomes, complications (22.7% vs. 5.9%), reintervention (18.2% vs. 0%, p = 0.056), and hospital stay (5.0 vs. 3.0 days, p = 0.070) were more frequent in the intervention group, likely due to the higher burden of advanced disease, although without statistically significant differences in most cases. In conclusion, the findings suggest that Del-Immune V® may modulate the perioperative inflammatory response, particularly through the reduction of IL-6. However, the imbalance in staging limits interpretation, and confirmation of these results in studies with larger sample sizes is recommended.

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000414

Date of Registration in Primary Registry:

06/01/2023

Record Verification Date:

2026/03/09

Next update date:

2027/03/09

Link to the spanish version:

Click here

Ensayos Registrados

Proceso de Registro

IVD in colon cancer

Acerca del RPCEC

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