Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia (HIT-CLL)

University of Surrey

Status: Enrolling

Conditions: Muscle Function; Lipid Cell; Tumor; Frailty; Chronic Lymphocytic Leukemia; Immune Function

Treatments: Behavioral: HIT; Behavioral: EXE+ Nutritional Guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT06379282

FHMS 21-22 263 EGA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 3 patient groups

HIT Group

Experimental group

Description:

Exercise Only * 3 sessions per week * Aerobic + Resistance Exercises

Treatment:

Behavioral: HIT

EXE+ Group

Experimental group

Description:

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

Treatment:

Behavioral: EXE+ Nutritional Guidance

Control Group

No Intervention group

Description:

Control group will receive no exercise or nutritional guidance