Status:
COMPLETED
Placebo-controlled Evaluation of Cocculine® Efficacy in the Management of Nausea After Chemotherapy in Breast Cancer.
Lead Sponsor:
Centre Leon Berard
Collaborating Sponsors:
BOIRON
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 wil...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
431 Patients enrolled
Trial Details
Trial ID
NCT00409071
Start Date
September 1 2005
End Date
October 1 2008
Last Update
February 5 2010
Active Locations (1)
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1
Centre Leon Berard
Lyon, France, 69000