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

NCT00409071 | Completed Phase 3

• 2 other identifiers: COCCULINEET2005-028
• Study Type: interventional
• Target: 431
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• 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

• 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

• 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

• 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

• 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.

Study Arms (2)

1

EXPERIMENTAL

cocculine

Drug: Cocculine®

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

Cocculine® DRUG

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.

1

placebo DRUG

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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnant or lactating women
• Follow-up impossible for social, geographical, familial or psychological reasons
• Patients who cannot be contacted by phone

Sponsors & Collaborators

• Centre Leon Berard: lead
• BOIRON: collaborator

Study Sites (1)

Centre Leon Berard

Lyon, 69000, France

Location

Related Publications (2)

• 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.

  PMID: 15084618 BACKGROUND

• 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.

  PMID: 23244208 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Nausea; Vomiting

Interventions

sinomenine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• RAY-COQUARD Isabelle, MD

  Centre Leon Berard, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 7, 2006
• First Posted: December 8, 2006
• Study Start: September 1, 2005
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: February 5, 2010

Record last verified: 2010-02

Locations

FR (1)