Supervised Exercise to Promote Infiltration of NK-cells Into the Tumor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Participatient Rate
研究概览
简要总结
'Supervised exercise to PRomote Infiltration of NK-cells into the Tumor? The objective of this feasibility study is to 1) study trial feasibility in terms of patient enrollment and the percentage of tumor biopsies that can be examined successfully, and 2) generate preliminary data on the potential effects of exercise on immune function assessed in the tumor and in blood.
详细描述
This is a multicenter randomized controlled feasibility trial, in which 20 women with breast cancer scheduled for neoadjuvant 2 or 3 weekly AC-T(H) chemotherapy will be randomized into a combined aerobic and resistance exercise intervention group or a usual care (no exercise) control group, during the first 6 weeks (2 or 3 cycles) of chemotherapy. Patients from the control group will receive care as usual and are requested to maintain their usual daily physical activities. In order to limit contamination (increase of exercise in the control group), non-participation and prevent dropout, the control group will be offered the same 6-week exercise intervention after the tumor biopsy has been taken after 6 weeks.
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
- 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
- •stage I-III breast cancer
- •scheduled for neoadjuvant chemotherapy with 2 or 3-weekly Adriamycin/Cyclofosfamide, followed by Paclitaxel weekly +/- trastuzumab
- •willing to undergo an additional ultrasound guided biopsy
- •ECOG-performance score ≤ 2 (able to perform basic activities of daily living such as walking or biking)
排除标准
- •addition of immuno- or targeted therapy at start of neoadjuvant chemotherapy
- •currently participating in structured vigorous aerobic exercise and/or resistance exercise
- •(≥2 days per week).
- •cognitive disorder or severe emotional instability
- •presence of other disabling co-morbidity that might hamper physical exercise e.g. heart failure (NYHA classes 3 and 4), chronic obstructive pulmonary disease (COPD, gold 3 and 4), orthopaedic conditions and neurological disorders (e.g., hernia, paresis, amputation, active rheumatoid arthritis);
- •immunosuppressive medication (e.g. corticosteroids (other than used as part of standard chemotherapy premedication protocol), cyclosporine)
- •immunodeficiency (primary or secondary)
- •impossibility to perform an ultrasound-guided biopsy of the tumor
研究组 & 干预措施
Controlgroup
Controlgroup, do not undergo supervised exercise for the first 6 weeks (possibility to undergo supervised exercise after 6 weeks).
Interventiongroup
Interventiongroup, undergo supervised exercise for the first 6 weeks.
干预措施: Supervised exercise (Behavioral)
结局指标
主要结局
Participatient Rate
时间窗: 6 weeks
Percentage of patient actually enrolled in the study of all patients who will be screened
Successful Examined Biopsies Rate
时间窗: 6 weeks
Percentage of tumor biopsies that can be examined successfully
次要结局
- Generate preliminary data(6 weeks)
研究者
Hans J. van der Vliet, MD, PhD
Prof. Dr.
Amsterdam UMC, location VUmc