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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
431
12 tablets in 3 days at each of the CT courses: 2 on the day before evening of the CT courses; 2 on the morning, noon and evening of the CT courses; 2 on morning and noon of the day after the CT courses.
12 tablets in 3 days at each of the CT courses: 2 on the day before evening of the CT courses; 2 on the morning, noon and evening of the CT courses; 2 on morning and noon of the day after the CT courses.
Centre Leon Berard
Lyon, France
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
Time frame: The nausea items of FLIE questionnaire are completed by patients on the 6th day of the 1st course.
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
Time frame: Nausea and vomiting items of FLIE questionnaire are completed by patients on the 6th day of the 1st, 2nd and 3rd adjuvant CT courses
Score of "nausea" calculated using the FLIE questionnaire at the time of the 2nd and 3rd adjuvant CT courses
Time frame: Nausea items of FLIE questionnaire are completed by patients on the 6th day of the 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
Time frame: Visual analogue scale are completed by patients the 1st five days of the 1st, 2nd and 3rd adjuvant CT courses
Rate of toxic effects (nausea and vomiting) recorded by investigators at the end of each of the 6 CT courses
Time frame: Recorded by investigators at the end of each of the 6 CT courses
Evaluation of compliance: patient autoevaluation and counting of remaining tablets
Time frame: 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.
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