Placebo-controlled Evaluation of Homeopathic Remedy (Cocculine®) Efficacy in the Management of Nausea After Adjuvant Chemotherapy in Non Metastatic Breast Cancer.
18 Years
N/A
Female
Breast Cancer
Trial Information
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
adjuvant CT
- patient compliance with Cocculine® dose.
Eligible patients will be randomly assigned to one of 2 arms: Cocculine® or placebo.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
The nausea items of FLIE questionnaire are completed by patients on the 6th day of the 1st course.
Safety Issue:
No
Principal Investigator
RAY-COQUARD Isabelle, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Leon Berard, France
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
COCCULINE
NCT ID:
NCT00409071
Start Date:
September 2005
Completion Date:
October 2008
Related Keywords:
- Breast Cancer
- Non metastatic breast cancer
- Adjuvant chemotherapy
- Nausea
- Vomiting
- Quality of life
- Homeopathy
- Breast Neoplasms
- Nausea
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