Placebo-controlled Evaluation of Cocculine® Efficacy in the Management of Nausea After Chemotherapy in Breast Cancer.

This study has been completed.
Sponsor:
Collaborator:
BOIRON
Information provided by:
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT00409071
First received: December 7, 2006
Last updated: February 4, 2010
Last verified: February 2010
  Purpose

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
Breast Cancer
Drug: Cocculine®
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo-controlled Evaluation of Homeopathic Remedy (Cocculine®) Efficacy in the Management of Nausea After Adjuvant Chemotherapy in Non Metastatic Breast Cancer.

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

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
Experimental: 1
cocculine
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.
Placebo Comparator: 2
placebo
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409071

Locations
France
Centre Leon Berard
Lyon, France, 69000
Sponsors and Collaborators
Centre Leon Berard
BOIRON
Investigators
Principal Investigator: RAY-COQUARD Isabelle, MD Centre Leon Berard, France
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zora ABDELBOST, Research Direction
ClinicalTrials.gov Identifier: NCT00409071     History of Changes
Other Study ID Numbers: COCCULINE, ET2005-028
Study First Received: December 7, 2006
Last Updated: February 4, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Leon Berard:
Non metastatic breast cancer
Adjuvant chemotherapy
Nausea
Vomiting
Quality of life
Homeopathy

Additional relevant MeSH terms:
Breast Neoplasms
Nausea
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2014