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

Breast Cancer Clinical Trial

Official title: Placebo-controlled Evaluation of Homeopathic Remedy (Cocculine®) Efficacy in the Management of Nausea After Adjuvant Chemotherapy in Non Metastatic Breast Cancer.

Status Completed

Clinical Trial 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.

Clinical Trial Description

The proportion of women with breast cancer treated by chemotherapy (CT) is increasing. CT-induced nausea and vomiting negatively impact patient quality of life.

The primary objective of the trial is to evaluate against a placebo the efficacy of Cocculine® administered as an adjunct to conventional treatments (corticosteroids and 5-HT3 receptor antagonists) for the management of nausea induced by a 1st course of adjuvant CT with FAC50, FEC100 or TAC in patients with non-metastatic breast cancer.

Secondary objectives are to test:

• the persistence of Cocculine® efficacy over the 2nd and 3rd CT courses

• the contribution of Cocculine® to the global management of nausea and vomiting during adjuvant CT

• patient compliance with Cocculine® dose.

Eligible patients will be randomly assigned to one of 2 arms: Cocculine® or placebo. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00409071
• Study type: Interventional
• Source: Centre Leon Berard
• Status: Completed
• Phase: Phase 3
• Start date: September 2005
• Completion date: October 2008