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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409071
• Other study ID #: COCCULINE
• Secondary ID: ET2005-028
• Status: Completed
• Phase: Phase 3
• First received: December 7, 2006
• Last updated: February 4, 2010
• Start date: September 2005
• Est. completion date: October 2008

Study information

• Verified date: February 2010
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 431
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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
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.

Locations

Country	Name	City	State
France	Centre Leon Berard	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Centre Leon Berard	BOIRON

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		The nausea items of FLIE questionnaire are completed by patients on the 6th day of the 1st course.	No
Secondary	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		Nausea and vomiting items of FLIE questionnaire are completed by patients on the 6th day of the 1st, 2nd and 3rd adjuvant CT courses	No
Secondary	Score of "nausea" calculated using the FLIE questionnaire at the time of the 2nd and 3rd adjuvant CT courses		Nausea items of FLIE questionnaire are completed by patients on the 6th day of the 2nd and 3rd adjuvant CT courses	No
Secondary	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		Visual analogue scale are completed by patients the 1st five days of the 1st, 2nd and 3rd adjuvant CT courses	No
Secondary	Rate of toxic effects (nausea and vomiting) recorded by investigators at the end of each of the 6 CT courses		Recorded by investigators at the end of each of the 6 CT courses	No
Secondary	Evaluation of compliance: patient autoevaluation and counting of remaining tablets		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.	No