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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Cocculine®; Drug: placebo

• Registration Number: NCT00409071
• Lead Sponsor: Centre Leon Berard

Brief 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.

Detailed 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 Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-12-07
• Study First Submitted QC: 2006-12-07
• Study First Posted: 2006-12-08
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-04
• Last Update Posted: 2010-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 431

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cocculine®	cocculine
2	placebo	placebo

Primary Outcome Measures

Name	Time	Method
Score of "nausea" calculated using the FLIE questionnaire (Functional Living index for Emesis with 5-day recall)at the time of the 1rst adjuvant CT course	The nausea items of FLIE questionnaire are completed by patients on the 6th day of the 1st course.

Secondary Outcome Measures

Name	Time	Method
Rate of toxic effects (nausea and vomiting) recorded by investigators at the end of each of the 6 CT courses	Recorded by investigators at the end of each of the 6 CT courses
Score of "nausea" calculated using the FLIE questionnaire at the time of the 2nd and 3rd adjuvant CT courses	Nausea items of FLIE questionnaire are completed by patients on the 6th day of the 2nd and 3rd adjuvant CT courses
Score of "vomiting" and global score of "nausea + vomiting" calculated using the FLIE questionnaire at the time of the 1st, 2nd and 3rd adjuvant CT courses	Nausea and vomiting items of FLIE questionnaire are completed by patients on the 6th day of the 1st, 2nd and 3rd adjuvant CT courses
Patient autoevaluation (D1-D5) of nausea severity using a visual analogue scale and of the frequency of vomiting during the 1st, 2nd and 3rd adjuvant CT courses	Visual analogue scale are completed by patients the 1st five days of the 1st, 2nd and 3rd adjuvant CT courses
Evaluation of compliance: patient autoevaluation and counting of remaining tablets	Patients register date and hour of tablets taking on a diary. Box remaining tablets will be count at the end of the 6 CT courses.

Trial Locations

Locations (1)

Centre Leon Berard; 🇫🇷 Lyon, France