Examining how exercise and diet affect health in chronic lymphocytic leukemia patients
Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia
This study is testing how exercise and diet can improve health in adults with chronic lymphocytic leukemia over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Surrey Academic / other |
| Drugs / interventions | chemotherapy, Prednisone |
| Locations | 1 site (Guildford) |
| Trial ID | NCT06379282 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of exercise training and dietary guidance on the health of adults diagnosed with chronic lymphocytic leukemia (CLL). Participants will be randomly assigned to one of three groups: an exercise-only program, an exercise program combined with nutritional guidance, or a control group with no exercise. The study will measure changes in physical fitness, immune function, and metabolic health through blood samples and fitness assessments at the beginning and end of the 12-week intervention. Additionally, follow-up assessments will be conducted 12 weeks post-intervention to evaluate any lasting effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of chronic lymphocytic leukemia who can engage in physical activity.
Not a fit: Patients with recent acute cardiac events or those on certain corticosteroid therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve physical fitness and immune function in patients with chronic lymphocytic leukemia.
How similar studies have performed: Other studies have shown positive outcomes with exercise and dietary interventions in cancer patients, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guildford
- University of Surrey — Guildford, United Kingdom (Recruiting)
Study contacts
- Principal investigator: David Bartlett, PhD — University of Surrey
- Study coordinator: David Bartlett, PhD
- Email: d.bartlett@surrey.ac.uk
- Phone: 01483 683 245
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.