Placebo-controlled Evaluation of Cocculine® Efficacy in the Management of Nausea After Chemotherapy in Breast Cancer.
Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
Participant gender:
Summary
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.