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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 27, 2014