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Sponsors and Collaborators: |
Centre Leon Berard BOIRON |
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Information provided by: | Centre Leon Berard |
ClinicalTrials.gov Identifier: | NCT00409071 |
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.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Cocculine® Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Placebo-Controlled Evaluation of Homeopathic Remedy (Cocculine®) Efficacy in the Management of Nausea After Adjuvant Chemotherapy in Non Metastatic Breast Cancer. |
Estimated Enrollment: | 431 |
Study Start Date: | September 2005 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
cocculine
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Drug: Cocculine®
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.
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2: Placebo Comparator
placebo
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Drug: placebo
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.
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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:
Eligible patients will be randomly assigned to one of 2 arms: Cocculine® or placebo.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Research Direction ( Zora ABDELBOST ) |
Study ID Numbers: | COCCULINE, ET2005-028 |
Study First Received: | December 7, 2006 |
Last Updated: | February 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00409071 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Non metastatic breast cancer Adjuvant chemotherapy Nausea |
Vomiting Quality of life Homeopathy |
Vomiting Skin Diseases Adjuvants, Immunologic Quality of Life |
Breast Neoplasms Nausea Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |