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: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Leon Berard
• Collaborator: BOIRON
• Treatments: Sinomenine

Criteria

Inclusion Criteria:

• Women with histologically proven non metastatic breast cancer

• No previous chemotherapy

• Treatment planning including 6 adjuvant CT courses with the first 3 being necessarily of the FAC50, FEC100 or TAC type

• Age>= 18 years

• ECOG performance status (PS) <= 2 (WHO scale)

• Patient able to read and understand French

• Written, voluntary, informed consent

Exclusion Criteria:

• Previous treatment with chemotherapy (including neo-adjuvant chemotherapy for breast cancer)

• Previous malignancies (except basal cell skin cancer or cervical cancer in situ or any other curatively treated malignancy in complete remission for more than 5 years)

• Contraindication to corticosteroids or 5-HT3 receptor antagonists

• Treatment with Cocculine® or any other anti-emetic drug in the 15 days before inclusion

• Pregnant or lactating women

• Follow-up impossible for social, geographical, familial or psychological reasons

• Patients who cannot be contacted by phone