Back to results

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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Cocculine®

placebo

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Non metastatic breast cancer, Adjuvant chemotherapy, Nausea, Vomiting, Quality of life, Homeopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Centre Leon Berard

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

cocculine

placebo

Outcomes

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

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

Score of "nausea" calculated using the FLIE questionnaire at the time of the 2nd and 3rd adjuvant CT courses

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

Rate of toxic effects (nausea and vomiting) recorded by investigators at the end of each of the 6 CT courses

Evaluation of compliance: patient autoevaluation and counting of remaining tablets

Full Information

NCT ID

NCT00409071

First Posted

December 7, 2006

Last Updated

February 4, 2010

Sponsor

Centre Leon Berard

Collaborators

BOIRON

1. Study Identification

Unique Protocol Identification Number

NCT00409071

Brief Title

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

Official Title

Placebo-controlled Evaluation of Homeopathic Remedy (Cocculine®) Efficacy in the Management of Nausea After Adjuvant Chemotherapy in Non Metastatic Breast Cancer.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Centre Leon Berard

Collaborators

BOIRON

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Non metastatic breast cancer, Adjuvant chemotherapy, Nausea, Vomiting, Quality of life, Homeopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

431 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

cocculine

Arm Title

Arm Type

Placebo Comparator

Arm Description

placebo

Intervention Type

Drug

Intervention Name(s)

Cocculine®

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Primary Outcome Measure Information:

Title

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.

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

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

Title

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.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

RAY-COQUARD Isabelle, MD

Organizational Affiliation

Centre Leon Berard, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Leon Berard

City

Lyon

ZIP/Postal Code

69000

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

15084618

Citation

Pommier P, Gomez F, Sunyach MP, D'Hombres A, Carrie C, Montbarbon X. Phase III randomized trial of Calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer. J Clin Oncol. 2004 Apr 15;22(8):1447-53. doi: 10.1200/JCO.2004.07.063.

Results Reference

background

PubMed Identifier

23244208

Citation

Perol D, Provencal J, Hardy-Bessard AC, Coeffic D, Jacquin JP, Agostini C, Bachelot T, Guastalla JP, Pivot X, Martin JP, Bajard A, Ray-Coquard I. Can treatment with Cocculine improve the control of chemotherapy-induced emesis in early breast cancer patients? A randomized, multi-centered, double-blind, placebo-controlled Phase III trial. BMC Cancer. 2012 Dec 17;12:603. doi: 10.1186/1471-2407-12-603.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs