Preliminary Efficacy of Different Exercise Training During Immunotherapy in Patients With Lung Cancer: The ENHANCE Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of Participants completing the exercise intervention sessions
研究概览
简要总结
The purpose of this study is to examine the feasibility and effects of 12-week exercise training at different intensities among individuals with advanced lung cancer receiving immune checkpoint inhibitors.
The names of the study interventions involved in this study are:
- High-intensity interval training (HIIT)
- Moderate-intensity continuous training (MICT)
- Usual care (UC)
详细描述
This single-center, three-armed, pilot randomized controlled research study will assess feasibility and compare immune activities, cardiorespiratory fitness, physical function, and immunotherapy-related adverse events, and patient-reported outcomes between three groups - high-intensity exercise, moderate-intensity exercise, and usual care.
Participants in this study will be randomly assigned to one of three groups:
- High-intensity interval training (HIIT)
- Moderate-intensity continuous training (MICT)
- Usual care (UC) The HIIT and the MICT groups will receive virtually supervised home-based exercise training three sessions per week for 12 weeks. The UC group will be asked not to change their baseline exercise behavior and will be offered to receive one of the exercise programs at the end of the initial 12 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
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Histologically diagnosed with non-small cell lung cancer (NSCLC).
- •Having been receiving immunotherapy for at least one month with a plan to continue for at least 12 weeks prospectively at the time of recruitment.
- •Medical clearance to perform exercise intervention and testing by their treating oncologist.
- •No uncontrolled medical conditions that could be exacerbated with exercise (e.g., uncontrolled hypertension or diabetes).
- •Ability to communicate and complete written forms in English.
- •Participate in less than or equal to 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month.
- •Ability to understand and the willingness to sign informed consent prior to any study-related procedures.
- •Willing to travel to DFCI for necessary data collection.
排除标准
- •Participate in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described exercise intervention, where additional exercise done regularly will contaminate the intervention outcomes.
- •Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of patients' safety, as well as because part of this study involves remote, home-based exercise where close supervision is not possible, patients with unstable medical conditions are excluded.
- •Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
- •Development of second malignancy (except for basal cell carcinoma or squamous cell carcinoma of the skin) that requires concurrent treatment, which would interfere with this study.
研究组 & 干预措施
Usual Care (UC)
Participants will be asked to maintain their baseline exercise behavior.
High-Intensity Interval Training (HIIT)
Patients in the HIIT group will perform alternating vigorous-intensity and recovery aerobic exercise intervals on a provided home stationary bike. The HIIT protocol consists of alternating a high-intensity exercise phase (1 min at 65-90% of workload corresponding to VO2peak) and a recovery phase (1 min at 30%), and the high-intensity and recovery intervals will be repeated 5-10 times in each session.
干预措施: High-Intensity Interval Training (HIIT) (Behavioral)
Moderate-Intensity Continuous Training (MICT)
The MICT group will perform an aerobic exercise at a continuous intensity in each session on a stationary bike. Similar to HIIT, the intensity will be progressed (47.5-60%). The total work of MICT is equalized with HIIT for training volume and frequency to compare the differences exerted from different intensities and energy expenditure.
干预措施: Moderate-Intensity Continuous Training (MICT) (Behavioral)
结局指标
主要结局
Proportion of Participants completing the exercise intervention sessions
时间窗: Up to 14 weeks
The primary outcome is feasibility and will be assessed by the proportion of enrolled participants completing the exercise intervention sessions with \>/=70% completion considered feasible.
次要结局
- Cardiopulmonary Fitness(Baseline (Week 1) and post-intervention (Week 14))
- Neutrophil-lymphocyte ratio (NLR)(Baseline (Week 1) and post-intervention (Week 14))
- Muscular Strength(Baseline (Week 1) and post-intervention (Week 14))
- Short Physical Performance Battery(Baseline (Week 1) and post-intervention (Week 14))
- Patient Reported Outcomes - Health-related quality of life(Baseline (Week 1) and post-intervention (Week 14))
- Patient Reported Outcomes - Sleep Quality(Baseline (Week 1) and post-intervention (Week 14))
- Patient Reported Outcomes - Immunotherapy Symptoms(Baseline (Week 1) and post-intervention (Week 14))
- Patient Reported Outcomes - Lung-cancer related quality of life(Baseline (Week 1) and post-intervention (Week 14))
- Patient Reported Outcomes - Anxiety and Depression(Baseline (Week 1) and post-intervention (Week 14))
研究者
Christina Dieli-Conwright, PhD
Principle Investigator
Dana-Farber Cancer Institute