Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Change from baseline in absolute number of CD19+/CD5+ CLL cells at week 12
研究概览
简要总结
This randomised control clinical trial aims to investigate the effects of exercise training and diet on physical and functional fitness and immunological and metabolic changes in adults with chronic lymphocytic leukaemia. Investigators will randomise participants to either 12 weeks of supervised/semi-supervised exercise only, exercise + nutritional guidance, or no exercise.
详细描述
This study aims to perform a randomised control trial of exercise or exercise plus nutritional guidance on the physiological and immunological health of adults diagnosed with chronic lymphocytic leukaemia (CLL). Recruited participants will be randomised to either 12 weeks of an exercise-only program, an exercise-plus nutritional guidance program or a no-exercise control group. Fasting blood samples collected at Baseline and 12 weeks will measure absolute CLL cell counts, immune function, and inflammatory and metabolic biomarkers. A series of physical fitness assessments will be assessed at baseline and 12 weeks to determine physiologic reserve and resilience against external stressors. Additionally, participants will be asked to return 12 weeks after completing the intervention to assess the legacy effects of the intervention on the same physiological and blood-based biomarkers of health.
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
- •Confirmed diagnosis of CLL (including small lymphocytic leukaemia) as per the International Workshop on CLL Guidelines.
- •Male or female ≥ 18 years of age
- •Able to walk on a treadmill or cycle on an ergometer
- •Pass the Physical Activity Readiness Questionnaires (PAR-Q and PAR-Q+)
排除标准
- •Corticosteroid therapy initiated less than 7 days before study entry. Prednisone 10mg or less or equivalent is allowed. Topical or inhaled corticosteroids are permitted.
- •Secondary malignancy within 3 years of study enrollment requiring intervention except for adequately treated basal, squamous cell carcinoma or non-melanomatous skin cancer, carcinoma in situ of the cervix, superficial bladder cancer not treated with intravesical chemotherapy or BCG within 6 months, localised prostate cancer and PSA stable.
- •Absolute contraindications to exercise: Recent (<6 months) acute cardiac event unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism and acute systemic infection.
- •Significant orthopaedic limitations, musculoskeletal disease and/or injury. Due to the nature of the study, persons with known joint, muscle or other orthopaedic limitations that restrict physical activity may be excluded.
- •Type I diabetes mellitus or uncontrolled Type II diabetes mellitus, or chronic obstructive pulmonary disease
- •Uncontrolled blood pressure (≥180/90) at rest
- •Known concurrent HIV, Hepatitis B or Hepatitis C
- •Unable to comply with other study requirements
结局指标
主要结局
Change from baseline in absolute number of CD19+/CD5+ CLL cells at week 12
时间窗: Baseline and 12 weeks
A blood sample will be taken and assessed for CD19+/CD5+ CLL frequency using flow cytometry and total lymphocyte counts to determine the absolute number of CLL cells in x10\^9/L
Change from baseline in cardiorespiratory fitness (CRF: VO2peak) at week 12
时间窗: Baseline and 12 weeks
Cardiopulmonary exercise testing will be conducted to assess changes in fitness
次要结局
- Muscle Strength and Endurance(Baseline and 12 weeks)
- Frailty(Baseline and 12 weeks)
- Change in systemic and cellular bioenergetics(Baseline and 12 weeks)
- Change in Quality of Life using the EORCT-QLQ-C30(Baseline and 12 weeks)
- Change in B-CLL Cell Function(Baseline and 12 weeks)
- Muscle Health(Baseline and 12 weeks)
- Change in muscle oxygen metabolism during a single bout of exercise(Baseline and 12 weeks)
研究者
David Bartlett
Senior Lecturer
University of Surrey