Physical Exercise During Neoadjuvant Chemotherapy for Breast Cancer as a Means to Increase Pathological Complete Response Rates: the Randomized Neo-ACT Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 712
- 试验地点
- 25
- 主要终点
- Pathological complete response
研究概览
简要总结
Neoadjuvant chemotherapy (NACT) is increasingly used in breast cancer. The best proof of NACT efficacy is pathological complete response (pCR), i.e. the absence of invasive tumour on post-NACT surgical histopathology. While it is known that physical exercise can help patients to better tolerate and complete often harsh cancer treatments, it is an emerging area of research to understand if and how exercise exerts anti-tumour effects and improves oncological outcomes.
The main aim of the Neo-ACT trial is to examine if a physical exercise intervention during NACT can increase pCR rates in breast cancer. Secondary aims are residual cancer burden, radiological tumour response, patient-related outcomes (health-related quality of life, physical activity), physiological outcomes (muscle strength, cardiorespiratory fitness), cancer treatment-related toxicities (cognitive dysfunction, chemotherapy completion rates) and long-term sick leave. Furthermore, the trial will explore how physical exercise affects anti-tumoral mechanisms inherent to therapy or host by hypothesis-generating translational analyses.
712 patients with primary invasive breast cancer will be randomized to either a supervised intervention of high-intensity interval and resistance training during NACT, supported by an exercise app, or to usual care, and followed for two years. Physical activity is meticulously tracked. By offering patients active involvement, the trial contributes strongly to the concept of personalized medicine.
详细描述
The Neo-ACT assesses the primary endpoint pathological complete response (pCR) and the secondary endpoints Residual Cancer Burden (RCB), objective tumour response (RECIST), all-cause, breast cancer-specific, and recurrence-free survival at 2, 5 and 10 years, health-related quality of life assessed by the EORTC QLQ-C30 and BR23 questionnaires, self-reported physical activity (Modified Godin Leisure Time Physical activity questionnaire), toxicity-related outcomes (chemotherapy completion rates, number of unplanned hospital admissions during NACT, objective cognitive dysfunction (Amsterdam Cognition Scan), cardiac toxicity and sick leave), device-measured physical activity level (Fitbit activity tracker), muscle strength (handgrip strength test and hypothetical 1-RM maximal leg muscle strength tests), and cardiorespiratory fitness (Ekblom-Bak submaximal cycle test).
Participants randomized to the exercise group will complete 120 min exercise sessions per week from initiation of NACT to surgery (approx. five months):
- Progressive home exercise program by an individualised mobile phone application, supported by local physiotherapists
- Initial exercise intensity individually tailored to each patient's fitness at baseline and rate of perceived exertion during the program and adapted if required
- Sessions will begin with a 3-minute moderate intensity (12-13 on Borg's Rate of Perceived Exertion (RPE) scale) warm-up.
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary invasive breast cancer cT1-T3 cN0-2
- •Full tumour biology available before initiation of NACT
- •Oral and written consent
- •Age ≥ 18 years
排除标准
- •Pregnancy or breast-feeding
- •Bilateral invasive breast cancer
- •The presence of musculoskeletal, neurological, respiratory, metabolic or cardiovascular conditions that may prevent safe completion of the exercise demands of the study
- •Currently performing equal to or more than 150 mins of moderate to high intensity aerobic exercise and 2 sessions per week of moderate intensity resistance exercise
结局指标
主要结局
Pathological complete response
时间窗: 5-6 months
Absence of residual invasive tumor in breast and axilla at surgery
次要结局
- Global health-related quality of life(baseline, after 1 and 2 years)
- Sick leave(pre-surgery and at 1- and 2-year follow-up)
- Chemotherapy completion rate(1 year)
- Cumulative chemotherapy dosage(1 year)
- Device-measured physical activity level(baseline and 5-6months (pre surgery))
- Handgrip strength(baseline and 5-6 months)
- Breast cancer-related quality of life(baseline, after 1 and 2 years)
- Self-reported physical activity(baseline, pre-surgery, 1- and 2-year follow-up)
- Muscle strength(baseline and 5-6 months)
- Radiological tumour response(5-6 months)
- Objective cognitive dysfunction(baseline and 1 year)
- Cardiorespiratory fitness(baseline and 5-6 months (pre-surgery))
- Residual Cancer Burden (RCB)(5-6 months)
研究者
Jana de Boniface
Ass. Prof, PI
Karolinska Institutet