Placebo-controlled Evaluation of Homeopathic Remedy (Cocculine®) Efficacy in the Management of Nausea After Adjuvant Chemotherapy in Non Metastatic Breast Cancer.
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
- patient compliance with Cocculine® dose.
Eligible patients will be randomly assigned to one of 2 arms: Cocculine® or placebo.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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.
RAY-COQUARD Isabelle, MD
Centre Leon Berard, France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)