Metastatic colorectal adenocarcinoma
Conditions
Interventions
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 aproxi
Dietary Supplements
Administration, Oral
Sponsors
Catalysis SL
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Cuba
Contacts
Public ContactIvis Mendoza Hernández
National Coordinator Center of Clinical Trials (CENCEC)
Outcome results
None listed