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

Phase 3
18 Years
Not Enrolling
Breast Cancer

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Trial Information

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

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.

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

- 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

- Pregnant or lactating women

- Follow-up impossible for social, geographical, familial or psychological reasons

- Patients who cannot be contacted by phone

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

The nausea items of FLIE questionnaire are completed by patients on the 6th day of the 1st course.

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Leon Berard, France


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

September 2005

Completion Date:

October 2008

Related Keywords:

  • Breast Cancer
  • Non metastatic breast cancer
  • Adjuvant chemotherapy
  • Nausea
  • Vomiting
  • Quality of life
  • Homeopathy
  • Breast Neoplasms
  • Nausea