Oncoxin®-Viusid®- Quality of life of patients with metastatic colorectal adenocarcinoma-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:

Evaluation of the effect of the nutritional supplement Oncoxin®-Viusid® on the quality of life of patients with metastatic colorectal adenocarcinoma. Phase II

Secondary indentifying numbers:

CAT-2017-1

Issuing authority of the secondary identifying numbers:

National Coordinator Center of Clinical Trials (CENCEC)

Source(s) of monetary or material support:

Catalysis SL Cuban Ministry of Public Health (MINSAP)

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 :

01/03/2018

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 Clinical Oncology

Affiliation:

National Institute of Oncology and Radiobiology (INOR)

Postal address:

29th Street and F, Plaza

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78364941

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 (INOR), January 4, 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:

11/06/2018

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:

Metastatic colorectal adenocarcinoma

Health condition(s) code:

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Rectal Diseases

Colonic Diseases

Intestinal Diseases

Gastrointestinal Diseases

Digestive System Diseases

Intervention(s):

Experimental group: Oncoxin®-Viusid® An oral solution of Oncoxin® (30 ml vials) will be used at a rate of 60 ml daily (1 vial every 12 hours), preferably administered after breakfast and dinner aproximately during 29 weeks. It will be prescribed for a period of 2 weeks before start the Chemotherapy (CT) up to 3 weeks after finish it. The treatment with Oncoxin®-Viusid® will continue in the possible periods of time of suspension of the CT treatment due to toxicities attributable to it. The treatment will be administered continuously for approximately 29 weeks from the patient's inclusion in the study.

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 (Instruments: EORTC QLQ-C30 and colorectal cancer specific QLQ-CR29, The final score and that of each item of both scales will be collected). Measurement time: at baseline, 3 months and final evaluation (4 weeks after finished the last cycle of chemotherapy).

Key secondary outcomes:

Effect variables 1. Tolerance (Compliance with the Chemotherapy scheme in time and at the planned doses. To assess the administration in time, the data related to administration or not of the QT in the planned time, number of the cycle administered out of date, Days elapsed since the previous cycle and, cause that caused the administration of the QT outside the planned date. In the case of the dose, the medication in which it was modified will be taken into account, as well as the modified dose). Measurement time: Month 3 and, in the final evaluation (4 weeks after finished the last cycle of chemotherapy). 2. Nutritional status (Calculation of the Body Mass Index (BMI = Weight (kg) / Size (cm)). Measurement Time: At baseline, after 3 months and in the final evaluation (4 weeks after finished the last cycle of chemotherapy). Security variables 3. Adverse event-AE. Measurement time: Month 3 and in the final evaluation (4 weeks after finished the last cycle of chemotherapy). The AE will measure by: - Occurrence of some AE in the subject (yes / no). - Type of AE (the AEs will be named by the terms used in the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.)) - Intensity of the AE: (Light, Moderate, Severe, Serious that threatens life or incapacitates the subject and Death). - Seriousness of the AE (serious or not serious) - Duration of the AE (Difference between the start and end date of the event) - Attitude regarding the treatment under study (no changes, dose modification, temporary or definitive interruption of the study treatment) - Result of the AE (recovered, improved, persisted or sequelae) - Causality relationship (very probable, probable, possible, improbable, unrelated, not evaluable).

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, resident in Cuba, with an age greater than or equal to 18 years. 2. Patients that meet the diagnostic criteria. 3. Patients with general health according to Karnofsky ≥70%. 4. Life expectancy greater than or equal to 3 months. 5. Patients eligible to receive chemotherapy FOLFOX-IV scheme. 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 , Platelet Count ≥100 x 109/L, Total bilirubin values ≤ 1.5 times the upper limit of the normal range established in the institution, AST and ALP values ≤2.5 times the upper limit of the normal interval established in the institution, Creatinine values within the normal limits of the institution.

Exclusion criteria:

1. Patients who are receiving another onco-specific product in research. 2. Patients with known hypersensitivity to (5 Fluoracil, folinic acid or oxaliplatin). 3. Decompensated intercurrent diseases, including hypertension, diabetes mellitus, ischemic heart disease, active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver damage or any other special condition that, at the discretion of the doctor, endangers their health and his life during the study or his participation in the trial. 4. Pregnant or lactating women. 5. 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. 6. Patients with cerebral metastases.

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:

40

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:

Ivis

Last Name:

Mendoza Hernández

Specialty:

Bachelor degree in Pharmaceutical Sciences. Master of Science in Pharmacology

Affiliation:

National Coordinator Center of Clinical Trials (CENCEC)

Postal Address:

5th A Street, Building CECMED-CENCEC 2nd floor & 60 and 62 Miramar, Playa.

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72164227

Email :

ivis@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 Clinical Oncology

Affiliation:

National Institute of Oncology and Radiobiology (INOR)

Postal Address:

29th Street and F, Plaza

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78364941

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:

RPCEC00000276

Date of Registration in Primary Registry:

05/06/2018

Record Verification Date:

2018/06/05

Next update date:

2019/06/05

Link to the spanish version:

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Oncoxin®-Viusid®- Quality of life of patients with metastatic colorectal adenocarcinoma-adults-Phase II

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