Placebo-controlled Evaluation of Homeopathic Remedy (Cocculine®) Efficacy in the Management of Nausea After Adjuvant Chemotherapy in Non Metastatic Breast Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 431
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
1
cocculine
干预措施: Cocculine® (Drug)
2
placebo
干预措施: placebo (Drug)
结局指标
主要结局
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
时间窗: The nausea items of FLIE questionnaire are completed by patients on the 6th day of the 1st course.
次要结局
- 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)
- 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)
- 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)
- 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)
- 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.)