A Randomized 3-arm Exercise Intervention Trial for Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 183
- 试验地点
- 2
- 主要终点
- Tumor size
研究概览
简要总结
The BENEFIT-Study is a randomized controlled 3-arm intervention trial investigating the currently discussed hypothesis that exercise concomitant to chemotherapy (CTx) may have a beneficial effect on cancer prognosis by boosting the anti-tumoral effect of the cytostatics or by enhancing therapy compliance. This hypothesis is based on pre-clinical and exploratory clinical trials. Breast cancer patients scheduled for neoadjuvant CTx will be randomized to either a resistance training or an aerobic training concomitant to the neoadjuvant CTx, or a waiting list control group that will get no exercise intervention during neoadjuvant CTx (i.e. usual care) but will exercise after breast surgery. The primary study endpoint is the tumor size. Further, the effects of resistance and aerobic exercise on the clinical-pathologic stage (CPS-EG) score, the pathological complete response (pCR), tolerability and compliance to CTx, physical fitness, patient reported outcomes such as fatigue, sleep problems, quality of life, depressive symptoms, anxiety and pain, as well as cognitive function, and selected biomarkers will be investigated.
A confirmation of the study hypothesis would be a strong argument for patients to engage in exercise as early as during neoadjuvant CTx. The trial will also provide evidence-based guidance for patients regarding type and timing of training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (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 ≥ 18 years of Age
- •Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy
- •Scheduled for neoadjuvant CTx (but not yet started)
- •Confirmed hormone receptor and Her2 status
- •Sufficient German language skills
- •Willing to train at the exercise facilities twice per week
排除标准
- •Any physical or mental conditions that would hamper the adherence to the training programs or the completion of the study procedures
- •Engaging in systematic intense exercise training (at least 1h twice per week)
结局指标
主要结局
Tumor size
时间窗: change from baseline (before start of neoadjuvant chemotherapy) to breast surgery
percentage of change from the maximal diameter of the lesion assessed before neoadjuvant chemotherapy (by mammography or sonography) to the maximal diameter of the tumor assessed after neoadjuvant chemotherapy at breast surgery
次要结局
- CPS-EG score(at breast surgery)
- Body mass index(at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery)
- Self-developed physical activity questionnaire including type, duration, frequency and intensity of sports, cycling,and walking(Follow-up (6 months and 12 months after breast surgery))
- Cognitive function - TMT(at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery)
- Cognitive function - COWA(at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery)
- Sleep quality(at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery)
- pCR(at breast surgery)
- Cognitive function - HVLT-R(at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery)
- Patient Health Questionnaire for Depression and Anxiety (PHQ-4)(at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery)
- Pittsburgh Sleep Quality Index (PSQI)(at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery)
- Sleep efficiency(at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery)
- Fatigue Assessment Questionnaire (FAQ)(at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery)
- EORTC QLQ-C30 / BR23(at baseline, week 9, post-chemotherapy (before breast surgery); months 6 and 12 after breast surgery)
- Spiroergometry (VO2max)(at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery)
- Isometric and isokinetic muscle strength measured by ISOMED 2000(at baseline, post-chemotherapy (before breast surgery); month 6 after breast surgery)