Placebo-controlled Evaluation of Cocculine® Efficacy in the Management of Nausea After Chemotherapy in Breast Cancer.

The purpose of the study is to determine whether a homeopathic remedy (Cocculine®) is effective in the prevention of chemotherapy-induced nausea in non metastatic breast cancer. Eligible patients will be randomly assigned to one of 2-arms: Cocculine® or placebo. The number of patients required to demonstrate a 0.5-point reduction in nausea on a visual analogue scale, assuming an alpha risk of 5% in a two-sided test and 85% power, is 396 (198 per arm). It has been estimated that the enrollment period should be 18 months.