NCT03559543

Evaluation of Ocoxin®-Viusid® in Metastatic Colorectal Adenocarcinoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Catalysis SL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Neoplasm
• Intestinal Neoplasms
• Gastrointestinal Neoplasms
• Digestive System Neoplasm
• Rectal Diseases
• Colonic Diseases
• Intestinal Disease
• Gastrointestinal Disease
• Digestive System Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ocoxin-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.

Timeline

• Start date: 2018-10-25
• Primary completion: 2022-06-30
• Completion: 2024-01-15
• First posted: 2018-06-18
• Last updated: 2024-02-07

Locations

1 site across 1 country: Cuba