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| ID | Type | Description | Link |
|---|---|---|---|
| ET2005-028 |
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| Name | Class |
|---|---|
| BOIRON | INDUSTRY |
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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.
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:
Eligible patients will be randomly assigned to one of 2 arms: Cocculine® or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | cocculine |
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| 2 | Placebo Comparator | placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| RAY-COQUARD Isabelle, MD | Centre Leon Berard, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Leon Berard | Lyon | 69000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15084618 | Background | 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. | |
| 23244208 | Derived |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C009271 | sinomenine |
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| 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. |
|
| 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. |
| 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |