NCT02963363终止不适用
Feasibility Study of an Adapted Physical Activity (APA) for Breast Cancer Patients Treated by Neoadjuvant Chemotherapy and Targeted Therapy Against HER2
Centre Jean Perrin2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年4月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Rate of patients reaching international physical activity recommendations for post-neoadjuvant chemotherapy assessment
研究概览
简要总结
The purpose of this study is to assess the feasibility of a home-based adapted physical activity during neoadjuvant chemotherapy for HER2+ breast cancer.
详细描述
After the assessment of their physical fitness, a home-based adapted physical activity program composed by aerobic and muscle strengthening exercises will be delivered to each patient. The aim of the intervention is to reach international recommendation in a progressive way during neoadjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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 > 18 years old
- •Patient with HER2 (Human Epidermal growth factor Receptor 2) positive breast cancer histologically proven, eligible for neoadjuvant chemotherapy and targeted therapy against HER-2
- •Affiliation to the French social security scheme
- •Patient who signed the participation consent before entering the trial
- •Medical fitness certificate for sport
排除标准
- •Diagnosis of a second malignancy in the past 5 years, with the exception of a basal cell skin cancer
- •Metastatic cancer
- •Karnofsky index ≤ 90%
- •Pregnant women
- •Significant psychiatric or neurological abnormality
- •Patient deprived of liberty by a court or administrative
- •Contraindication for physical activity
- •Patient unable to complete questionnaires (language barrier)
- •Participation in a clinical trial with the same objective
结局指标
主要结局
Rate of patients reaching international physical activity recommendations for post-neoadjuvant chemotherapy assessment
时间窗: Change from baseline (T0: before neoadjuvant chemotherapy) at the 5 months (T1: end of neoadjuvant chemotherapy)
Time spent to physical activity and sedentariness will be evaluated by Recent Physical Activity Questionnaire (RPAQ)
次要结局
- Physical capacity : VO2max(Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy)
- Lipid profile : total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides(Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy)
- Physical capacity : Voluntary muscular strength(Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy)
- Ventricular ejection fraction assessed by echocardiography or cardiac scintigraphy(Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy)
- Changes of cancer treatment(At each cycle of neoadjuvant chemotherapy : every three weeks during 5 months)
- Quality of life : Quality of Life Questionnaire-C30(Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy)
- Physical capacity : six-minutes walking distance test(Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy)
- Assessment of physical activity level using a validated smartphone application (eMouveRecherche)(Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy)
- Longitudinal evolution of RPAQ score(Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy)
- Asthenia : Multidimensional Fatigue Inventory-20(Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy)
- Anthropometrics measurements(Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy)
研究者
研究点 (2)
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