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

Léon Bérard Center

Status and phase

Completed

Phase 3

Conditions

Breast Cancer

Treatments

Drug: Cocculine®

Drug: placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00409071

ET2005-028

COCCULINE

Details and patient eligibility

About

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.

Full 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.

Enrollment

431 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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