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:

Effect of the metabiotic Del-Immune V during chemotherapy treatment 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

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78761632

+53-52706385

Email address:

gisselgarcia@infomed.sld.cu [1]

gisselgarcia2805@gmail.com [2]

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:

Recruiting

Date of first enrollment:

22/12/2022

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):

Group A (control): chemotherapy (QT) FOLFOX OR CAPEOX, (intravenous administration) + placebo, in the same way as group B. 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. Treatment for both groups will be administered continuously for 29 weeks from patient enrollment.

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):

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.

Key secondary outcomes:

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. 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. 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.

Selection criterias

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

Gender:

Male/Female

Minimum age:

18 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. 3 - Patients with a general state of health according to Karnofsky ≥70%. 4 - Life expectancy greater than or equal to 3 months. 5 - Patients eligible to receive chemotherapy scheme FOLFOX-IV, XELOX or XELIRI. 6 - Patients who have signed the informed consent. 7 - Patients who have laboratory values in parameters that do not contraindicate the administration of chemotherapy: - 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.

Exclusion criteria:

1 - Pregnant or lactating patients 2 - Patients with known hypersensitivity to 5-Fluoracil, Folinic Acid, Oxaliplatin, Capecitabine or Irinotecan. 3 - Patients who are receiving another investigational product. 4 - 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. 5 - Patients with brain metastases. 6 - 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.

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

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78761632

Email :

gisselgarcia@infomed.sld.cu [1]

gisselgarcia280@gmail.com [3]

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

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78761632

Email :

gisselgarcia@infomed.sld.cu [1]

gisselgarcia2805@gmail.com [2]

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

Email:

hha@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

10/09/2024

Date of available results:

30/10/2024

Date of first publication:

27/12/2024

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:

2023/02/13

Next update date:

2024/02/13

Link to the spanish version:

Click here [4]