Oncoxin-Viusid/Stomach and gastric esophagus union cancer / Adults / Phase II

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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 nutritional supplement Oncoxin-Viusid in the quality of life of patients with advanced cancer of the stomach and gastric esophagus union.

Secondary indentifying numbers:

CAT-2017-3

Issuing authority of the secondary identifying numbers:

National Coordinator Center of Clinical Trials (CENCEC)

Source(s) of monetary or material support:

Laboratorios Catalysis, SL

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:

Trials notification

Regulatory instance:

Institute of Nutrition and Hygiene of food(INHA)

Notification date :

13/02/2018

Reference number:

Not applicable

Principal investigator

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

First name:

Luis

Midle name:

Enrique

Last name:

Alsina Tul

Medical Specialty :

First degree specialist in Oncology

Affiliation:

National Institute of Oncology and Radiobiology

Postal address:

29th Street esq. F, Plaza

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78382574

Email address:

lealsina@infomed.sld.cu

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

Research ethics committees:

National Institute of Oncology and Radiobiology, March 4th, 2018.

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

14/05/2018

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:

cancer of the stomach and gastric esophagus union.

Health condition(s) code:

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Esophageal Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Digestive System Diseases

Esophageal Diseases

Stomach Diseases

Esophagogastric Junction

Intervention(s):

Oncoxin-Viusid group (Experimental). Oral solution of Oncoxin-Viusid (vials of 30 ml), at a rate of 60 ml daily (1 vial every 12 hours), administrado preferably administered after breakfast and dinner. The product will dilute in water, milk or juice. The treatment will have a period of 19 weeks, starting 2 weeks before the onco-specific treatment with FOLFOX chemotherapy and will end 3 weeks after the end of the sixth cycle of chemotherapy. QT FOLFOX will be prescribed intravenously every 14 days for 6 cycles as follows: Oxaliplatin (85 mg x m2) on day 1 Folinic acid (200 mg x m2) on day 1 and 2 5 Fluoracil (400 mg x m2, bolus) on day 1 and 2 5 Fluoracil (600 mg x m2, continuous infusion) on day 1 and 2

Intervention code:

Dietary Supplements

Administration, Oral

Intervention keyword:

Oncoxin viusid

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):

Quality of life. Measurement time: at baseline and, at a week after end of treatment. It will measured by: - EORTC QLQ-C30 (score of every item and global score). - EORTC EORTC QLQ-STO22 if gastric cancer (score of every item and global score). - EORTC QLQ-OG25 if is a gastric esophagus union cancer (score of every item and global score). - Karnofsky index (Score of 0-100 points at intervals of 10).

Key secondary outcomes:

1. Tolerance to Chemotherapy (It will consider the compliance to the Chemotherapy treatment in terms of time and doses plan and, it will classify in “Yes, No”). Measurement time: at each cycle of CT and, 1 week after end of treatment. 2. Nutritional status (Body Max Index calculated by Weight/(Height*Height), the weight expressed in Kg and, the height expressed in meters). Measurement time: At baseline and, 1 week after end of treatment. 3. Adverse Events-AE. Measurement time: In the two weeks prior to the QT, in the evaluation corresponding to each QT cycle and 1 week after the end of the treatment. AE will be measured as: - Type of AE (Description of the EA that is presented) - Causal Agent (QT, Oncoxin -Viusid, Other) - Seriousness of the AE (Serious, Not serious) - Intensity of the AE (Mild, Moderate, Severe, Life-threatening consequences, Death, according to the Common Criteria of Adverse Event Terminology (CTCAE) version 4.0) - Duration of the AE (Difference between the start and end date of the event) - Causal relationship (Very likely/Definitive, Probable, Possible, Unlikely, Not related, Not assessable/Not classifiable according to the WHO classification) - Attitude towards treatment (No change, Modification of doses, Temporary interruption, Definitive interruption). 4. Results of laboratory tests (Hematological (hemoglobin, platelets, total leukocytes, CAN) and Blood chemistry (AST, ALT, total bilirubin, creatinine, glycemia, albumin, total proteins, alkaline phosphatase) .The values will be recorded according to the units established for each test, reporting as normal, abnormal, not clinically significant, abnormal clinically significant and not performed, according to the normality ranges of the institution). Measurement time: at baseline and, 1 week after 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 años

Maximum age:

None

Inclusion criteria:

1. Patients with cyto-histological diagnosis of stomach adenocarcinoma and gastric esophageal junction in stages III and IV, which are tributaries of the FOLFOX chemotherapy scheme. 2. Patients of any sex with age ≥ 18 years. 3. Patients with clinical status according to Karnofsky index ≥ 70%. 4. Patients with life expectancy ≥ 3 months. 5. Clinically fit patients to receive the FOLFOX chemotherapy scheme. 6. Patients who have signed informed consent for the investigation. 7. Patients with laboratory parameters within normal limits 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 ≤ 1.5 times the upper limit of the normal range established in the institution, TGO / TGP ≤2.5 times the upper limit of the normal range established in the institution, creatinine within the limits normal of the institution. 8. Patients of childbearing age with negative pregnancy test and use appropriate contraceptive methods such as intrauterine devices, barrier or tubal ligation methods, hormonal contraceptives. In the case of male sex (vasectomy, use of condoms) while the treatment lasts.

Exclusion criteria:

1. Patients with stomach cancer and gastric esophageal junction in stages III and IV, tributaries of surgical treatment and / or radiotherapy. 2. Patients who are being treated with another product under investigation. 3. Patients with known hypersensitivity to any component of the investigational product. 4. Patients with known hypersensitivity to any component of the Chemotherapy (FOLFOX). 5. Patients with acute allergic states or history of severe allergic reactions. 6. Patients with acute, chronic, or inflammatory decompensated infectious diseases. 7. Patients with brain metastases. 8. Patients with psychiatric disorders that make it difficult to collect information, treatment or follow-up. 9. Patients in the period of breast-feeding or puerperium.

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:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

2

Target sample size:

45

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:

Pedro

Middle Name:

Pablo

Last Name:

Guerra Chaviano

Specialty:

Industrial Engineer. Master of Clinical Trials

Affiliation:

National Coordinator Center of Clinical Trials (CENCEC)

Postal Address:

5th A Street between 60th Street and 62nd street, Miramar, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72164124

Email :

pedrop@cencec.sld.cu

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:

Luis

Middle Name:

Enrique

Last Name:

Alsina Tul

Specialty:

First degree specialist in Oncology

Affiliation:

National Institute of Oncology and Radiobiology (INOR)

Postal Address:

29th Street esq. F, Plaza

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78388589

Email :

lealsina@infomed.sld.cu

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:

RPCEC00000272

Date of Registration in Primary Registry:

10/05/2018

Record Verification Date:

2018/05/10

Next update date:

2019/05/10

Link to the spanish version:

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Oncoxin-Viusid/Stomach and gastric esophagus union cancer / Adults / Phase II

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