Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Centre Leon Berard
With
BOIRON
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Placebo-controlled Evaluation of Cocculine® Efficacy in the Management of Nausea After Chemotherapy in Breast Cancer.