drugset / Trial / NCT03576521
Evaluation of Ocoxin®-Viusid® in Breast Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ocoxin-Viusid | Other / unclassified | 75 ml | Oral |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | — |