Clinical trial NCT06379282: Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia
Official title: Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Lymphocytic Leukemia
Frailty
Muscle Function
Immune Function
Lipid Cell; Tumor
Lead sponsor: University of Surrey
Sponsor class: OTHER
Collaborators: name: American Society of Hematology
First posted: 2024-04-23
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Recruited participants will be randomised to either exercise only, exercise + nutritional guidance, or control for 12 weeks
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in absolute number of CD19+/CD5+ CLL cells at week 12
timeFrame: Baseline and 12 weeks
measure: Change from baseline in cardiorespiratory fitness (CRF: VO2peak) at week 12
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Frailty
timeFrame: Baseline and 12 weeks
measure: Muscle Strength and Endurance
timeFrame: Baseline and 12 weeks
measure: Muscle Health
timeFrame: Baseline and 12 weeks
measure: Change in Quality of Life using the EORCT-QLQ-C30
timeFrame: Baseline and 12 weeks
measure: Change in muscle oxygen metabolism during a single bout of exercise
timeFrame: Baseline and 12 weeks
measure: Change in B-CLL Cell Function
timeFrame: Baseline and 12 weeks
measure: Change in systemic and cellular bioenergetics
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Legacy Effect of Intervention on change in cardiorespiratory fitness (VO2peak) as measured by a cardiopulmonary exercise test
timeFrame: 12 weeks to 24 weeks
measure: Legacy Effect of Intervention on absolute number of CD19+/CD5+ CLL cells
timeFrame: 12 weeks to 24 weeks
Locations:
city: Guildford
country: United Kingdom
facility: University of Surrey
Study officials:
affiliation: University of Surrey
name: David Bartlett, PhD
role: PRINCIPAL_INVESTIGATOR
References: