A Phase II Exercise RCT for AML Patients Undergoing Induction Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Change from baseline in fatigue at weeks 4-6 (post-induction) and weeks 10-12 (post-consolidation 1)
研究概览
简要总结
Reduced quality of life, fatigue, and loss of physical function are common in patients getting chemotherapy for acute myeloid leukaemia (AML). The investigators completed a pilot study showing that exercise during active chemotherapy for AML is feasible, safe, and may improve symptoms and physical function. The investigators now propose to compare our hospital-based supervised exercise program to usual care to see if exercise can improve symptoms, physical function, and improve treatment tolerability.
详细描述
Acute myeloid leukaemia (AML) is a life-threatening malignant blood disorder. Curative treatment requires multiple cycles of intensive chemotherapy. The first cycle, induction, is the most intense and intended to achieve complete disease remission (CR). Induction therapy requires 4-6 weeks of inpatient admission and is associated with extended bed rest and multiple toxicities, leading to physical deconditioning. Regular exercise during induction may reduce declines in physical fitness, leading to improved quality of life (QOL), reduced fatigue, improved tolerance of chemotherapy, and potentially greater survival. Four prior studies of exercise in AML patients undergoing induction have suggested improvements in QOL, fatigue, physical function, and treatment tolerability. However, all 4 studies suffered from major limitations including small sample sizes, design limitations, generalizability concerns, and limited safety information. The investigators conducted a pilot non-randomized study in 35 AML patients and demonstrated feasibility, safety, and potential improvements in QOL, fatigue, and physical fitness outcomes. The investigators now propose a rigorous evaluation of the intervention in a phase II randomized controlled trial (RCT).
Primary objectives include: (1) To determine the efficacy of a supervised mixed-modality exercise program during induction chemotherapy on QOL and fatigue; (2) To determine the efficacy on physical fitness. Our secondary objective is to determine the efficacy on AML treatment tolerability (hospital length of stay, development of sepsis, intensive care unit (ICU) admission, delays in consolidation chemotherapy).
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
- •Is ≥ 18 years old
- •Has newly diagnosed AML, or relapsed AML after having been in CR for at least 6 months
- •Is initiating induction chemotherapy
- •Is ambulatory without need for human assistance
- •Has consented to study
- •Is medically cleared for participation by the attending physician
排除标准
- •Has another active malignancy
- •Has life expectancy < 1 month, physician determined
- •Has significant comorbidity
- •Has uncontrolled pain
- •Has haemodynamic instability
- •Lacks fluency in reading and writing English, and there is no translator available for each visit
结局指标
主要结局
Change from baseline in fatigue at weeks 4-6 (post-induction) and weeks 10-12 (post-consolidation 1)
时间窗: Baseline (within 5 days of starting chemo), Post-induction (weeks 4-6), Post-consolidation (weeks 10-12)
FACT-F (questionnaire)
Change from baseline in quality of life at weeks 4-6 (post-induction) and weeks 10-12 (post-consolidation 1) (QOL)
时间窗: Baseline (within 5 days of starting chemo), Post-induction (weeks 4-6), Post-consolidation (weeks 10-12)
EORTC QLQ-C30 (questionnaire)
Change from baseline in fitness measures at weeks 4-6 (post-induction) and weeks 10-12 (post-consolidation 1)
时间窗: Baseline (within 5 days of starting chemo), Post-induction (weeks 4-6), Post-consolidation (weeks 10-12)
The fitness assessment will encompass various measures to assess physical fitness. The following measures will be completed: VO2 peak (a measure of aerobic capacity), 6-minute walk test, grip strength and maximal leg strength, chair stands.
次要结局
- Treatment tolerability(Post-induction (weeks 4-6), Post-consolidation (weeks 10-12))