Colonic Diseases, Colorectal Neoplasm, Digestive System Disease, Digestive System Neoplasm, Gastrointestinal Disease, Gastrointestinal Neoplasms, Intestinal Disease, Intestinal Neoplasms, Rectal Diseases
Conditions
Keywords
Nutritional supplement, Metastatic colorectal Cancer, Oxidative Stress, Ocoxin Viusid, Antioxidant
Brief summary
The research product, registered as a nutritional supplement (Ocoxin®, oral solution), manufactured by Laboratorios Catalysis S. L., comes in the form of single-dose vials of 30 ml. It will be used at a rate of 60 ml daily (1 vial every 12 hours). Our main objective is To evaluate the effect of Ocoxin®-Viusid® on the quality of life of patients with metastatic colorectal adenocarcinoma. Our hypothesis is that the administration of the nutritional supplement Ocoxin®-Viusid® it is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients.
Detailed description
* To evaluate the effect of Ocoxin®-Viusid® on the quality of life of patients. * To evaluate the influence of Ocoxin®-Viusid® on tolerance to onco-specific therapy. * Identify the changes that occur in the nutritional status of patients receiving the supplement. * To evaluate the toxicity of Ocoxin®-Viusid® in combination with chemotherapy in patients with metastatic colorectal adenocarcinoma.
Interventions
DIETARY_SUPPLEMENTOcoxin-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 lunch. It will be prescribed for a period of 2 weeks before starting the QT up to 3 weeks after finishing the treatment. The treatment with Oncoxin®-Viusid® will continue in the possible periods of time of suspension of the chemotherapy treatment due to toxicities attributable to the oncospecific treatment. The treatment will be administered continuously for approximately 29 weeks from the patient's inclusion in the study.
Sponsors
Catalysis SL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of any sex, resident in Cuba, with an age greater than or equal to 18 years. * Patients that meet the diagnostic criteria. * Patients with general health according to Karnofsky ≥70%. * Life expectancy greater than or equal to 3 months. * Patients eligible to receive FOLFOX-IV chemotherapy. * Patients who have signed the informed consent. * 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. * TGO and TGP 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
* Pregnant or lactating patients. * Patients with known hypersensitivity to (5 Fluoracil, Folinic Acid or Oxaliplatin). * Patients who are receiving another product under investigation. * Patients with 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 puts their health at risk and his life during the study or his participation in the trial. * Patients with brain metastases. * Patients with mental disorders that may limit adherence to the requirements of the clinical trial and may hinder the collection of information, treatment or follow-up. It is planned to include a total of 40 patients in the study, taking into account 10% of losses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 8 months | Evaluated through the European Organisation for Research and Treatment of Cancer (EORTC) CV instruments: EORTC QLQ-C30 (general quality of life in cancer patients: Physical, Role, Emotional, Cognitive, Social, Overall quality of life, Fatigue, Nausea and vomiting, Pain valorated from 1 to 4) |
| Tolerance of Chemotherapy | 8 months | Treatment with chemotherapy (CT) FOLFOX-IV will be considered |
| Nutritional status | 8 months | Variations in the patient's nutritional status and weight at the end of treatment will be considered |
Countries
Cuba
Outcome results
None listed