Evaluation of Ocoxin®-Viusid® in Metastatic Colorectal Adenocarcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Effect of the Ocoxin®-Viusid® Nutritional Supplement on the Quality of Life of Patients With Metastatic Colorectal Adenocarcinoma. Phase II

Conditions
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Colorectal Neoplasm, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasm, Rectal Diseases, Colonic Diseases, Intestinal Disease, Gastrointestinal Disease, Digestive System Disease

Intervention / Treatment
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* Dietary Supplement: Ocoxin-Viusid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ocoxin-Viusid®<br> | Dietary Supplement: Ocoxin-Viusid<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | 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) | 8 months | 
| Quality of life | Evaluated through the European Organisation for Research and Treatment of Cancer (EORTC) CV instruments: QLQ-CR29 specific questionnaire of quality of life in colon cancer (Urinary frequency, Blood and mucus in stool, Stool frequency and Body image, Urinary incontinence, Dysuria, Abdominal pain, Buttock pain , Bloating, Dry mouth, Hair loss, Taste, Anxiety, Weight, Flatulence, Faecal incontinence, Sore skin, Embarrassment, Stoma care problems, Sexual interest, Impotence, Dyspareunia valorated from 1 to 4). | 8 months | 
| Tolerance of Chemotherapy | Treatment with chemotherapy (CT) FOLFOX-IV will be considered | 8 months | 
| Nutritional status | Variations in the patient's nutritional status and weight at the end of treatment will be considered | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antioxidant, Nutritional supplement, Metastatic colorectal Cancer, Oxidative Stress, Ocoxin Viusid