Chronic Lymphocytic Leukemia, Frailty, Muscle Function, Immune Function, Lipid Cell; Tumor
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALHIT
Exercise training only
BEHAVIORALEXE+ Nutritional Guidance
Exercise Training + Nutritional Guidance
Sponsors
American Society of Hematology
University of Surrey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Recruited participants will be randomised to either exercise only, exercise + nutritional guidance, or control for 12 weeks
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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+)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in absolute number of CD19+/CD5+ CLL cells at week 12 | 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 | Baseline and 12 weeks | Cardiopulmonary exercise testing will be conducted to assess changes in fitness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Strength and Endurance | Baseline and 12 weeks | Estimated one repetition maximum and repetitions to failure using machine-based weights |
| Muscle Health | Baseline and 12 weeks | Ultrasound and near-infrared spectroscopy assessment of muscle fuel usage |
| Change in muscle oxygen metabolism during a single bout of exercise | Baseline and 12 weeks | Measurement of muscle oxygenation via near infrared spectroscopy during a single session of acute exercise |
| Change in B-CLL Cell Function | Baseline and 12 weeks | Measurement of in vitro B-CLL cell proliferation by flow cytometry |
| Change in systemic and cellular bioenergetics | Baseline and 12 weeks | Measurement of in vitro immune cell fuel utilisation by high resolution respirometry and mass spectrometry |
| Change in Quality of Life using the EORCT-QLQ-C30 | Baseline and 12 weeks | Quality of life will be determined by the EORCT-QLQ-C30 questionnaire |
| Frailty | Baseline and 12 weeks | Frailty will be determined by a series of validated physical function tests that provide a score of 0-1(Robust), 2 (Pre-Frail), 3-5 (Frail) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Legacy Effect of Intervention on change in cardiorespiratory fitness (VO2peak) as measured by a cardiopulmonary exercise test | 12 weeks to 24 weeks | Reassessment of CRF following 12 weeks of unguided exercise training |
| Legacy Effect of Intervention on absolute number of CD19+/CD5+ CLL cells | 12 weeks to 24 weeks | Reassessment of absolute number of CD19+/CD5+ CLL cells following 12 weeks of unguided exercise training |
Countries
United Kingdom
Contacts
Primary ContactDavid Bartlett, PhD
Backup ContactEllie Miles
Outcome results
None listed