NCT06379282 Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia
| NCT ID | NCT06379282 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Surrey |
| Condition | Chronic Lymphocytic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2022-10-14 |
| Primary Completion | 2025-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 132 participants in total. It began in 2022-10-14 with a primary completion date of 2025-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
David Bartlett, PhD
PRINCIPAL INVESTIGATOR
University of Surrey
Frequently Asked Questions
Who can join the NCT06379282 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Lymphocytic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06379282 currently recruiting?
Yes, NCT06379282 is actively recruiting participants. Contact the research team at d.bartlett@surrey.ac.uk for enrollment information.
Where is the NCT06379282 trial being conducted?
This trial is being conducted at Guildford, United Kingdom.
Who is sponsoring the NCT06379282 clinical trial?
NCT06379282 is sponsored by University of Surrey. The principal investigator is David Bartlett, PhD at University of Surrey. The trial plans to enroll 132 participants.
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