Clinical trial · Interventional
Placebo-controlled Evaluation of Cocculine® Efficacy in the Management of Nausea After Chemotherapy in Breast Cancer.
Placebo-controlled Evaluation of Homeopathic Remedy (Cocculine®) Efficacy in the Management of Nausea After Adjuvant Chemotherapy in Non Metastatic Breast Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cocculine® | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- cocculine
- interventionNames
- Drug: Cocculine®
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- placebo
- interventionNames
- Drug: placebo
Primary outcomes (1)
- 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
- timeFrame
- The nausea items of FLIE questionnaire are completed by patients on the 6th day of the 1st course.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDPommier 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
- DERIVEDPerol 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