Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia

Not Applicable

Recruiting

• Conditions: Chronic Lymphocytic Leukemia; Frailty; Muscle Function; Immune Function; Lipid Cell; Tumor
• Interventions: Behavioral: HIT; Behavioral: EXE+ Nutritional Guidance

• Registration Number: NCT06379282
• Lead Sponsor: University of Surrey

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.

Study Timeline

• Study Start: 2022-10-14
• Study First Submitted: 2024-02-09
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-22
• Study First Posted: 2024-04-23
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Primary Completion: 2025-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIT Group	HIT	Exercise Only * 3 sessions per week * Aerobic + Resistance Exercises
EXE+ Group	EXE+ Nutritional Guidance	Exercise + Nutritional Guidance * 3 sessions per week * Aerobic + Resistance Exercises * Dietary assessment at baseline and during with guidance on eating a healthy diet provided

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Muscle Strength and Endurance	Baseline and 12 weeks	Estimated one repetition maximum and repetitions to failure using machine-based weights
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)
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
Change in B-CLL Cell Function	Baseline and 12 weeks	Measurement of in vitro B-CLL cell proliferation by flow cytometry
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

Trial Locations

Locations (1)

University of Surrey; 🇬🇧 Guildford, United Kingdom