drugset / Trial / NCT03576521

Evaluation of Ocoxin®-Viusid® in Breast Cancer

NCT03576521 ↗

Phase 2 Completed 120 enrolled Catalysis SL
RandomizedParallel-groupTriple-blindSupportive care

Summary

The purpose is to determine the efficacy of the nutritional supplement Ocoxin-Viusid oral solution (OV) in the reduction of acute toxicity of Chemotherapy (CT) treatment with patients with breast carcinoma. A randomized, double-blind phase II clinical trial was designed, with a sample of 120 patients distributed in 2 arms: 60 patients will receive the CT treatment plus the OV, 60 will receive CT plus OV placebo. The OV / placebo will be administered before, during and 3 weeks after the conclusion of the CT. A better tolerance to the treatment is expected with the addition of the nutritional supplement.

Timeline

Start
2015-05-13
Primary completion
2018-01-01
Completion
2018-02-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Ocoxin-Viusid Other / unclassified 75 ml Oral
Background Cyclophosphamide Other / unclassified — Intravenous
Background Doxorubicin Other / unclassified 60 mg/m2 —