Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Surrey
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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+)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
HIT
BehavioralExercise training only
EXE+ Nutritional Guidance
BehavioralExercise Training + Nutritional Guidance
Treatment groups
132 Participants
are divided into 3 treatment groupsGroup A: HIT GroupExperimental treatment 1 intervention
Group B: EXE+ GroupExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change from baseline in absolute number of CD19+/CD5+ CLL cells at week 12
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
Time frame
Baseline and 12 weeks2
Change from baseline in cardiorespiratory fitness (CRF: VO2peak) at week 12
Cardiopulmonary exercise testing will be conducted to assess changes in fitness
Time frame
Baseline and 12 weeksSecondary outcomes
1
Frailty
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)
Time frame
Baseline and 12 weeks2
Muscle Strength and Endurance
Estimated one repetition maximum and repetitions to failure using machine-based weights
Time frame
Baseline and 12 weeks3
Muscle Health
Ultrasound and near-infrared spectroscopy assessment of muscle fuel usage
Time frame
Baseline and 12 weeks4
Change in Quality of Life using the EORCT-QLQ-C30
Quality of life will be determined by the EORCT-QLQ-C30 questionnaire
Time frame
Baseline and 12 weeksOther outcomes
1
Legacy Effect of Intervention on change in cardiorespiratory fitness (VO2peak) as measured by a cardiopulmonary exercise test
Reassessment of CRF following 12 weeks of unguided exercise training
Time frame
12 weeks to 24 weeks2
Legacy Effect of Intervention on absolute number of CD19+/CD5+ CLL cells
Reassessment of absolute number of CD19+/CD5+ CLL cells following 12 weeks of unguided exercise training
Time frame
12 weeks to 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Surrey
Lead sponsor
American Society of Hematology
Collaborator
Source ClinicalTrials.gov