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

Last updated: April 23, 2024
Sponsor: University of Surrey
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Chronic Lymphocytic Leukemia

Lymphoproliferative Disorders

Treatment

EXE+ Nutritional Guidance

HIT

Clinical Study ID

NCT06379282
FHMS 21-22 263 EGA
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Confirmed diagnosis of CLL (including small lymphocytic leukaemia) as per theInternational 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

Exclusion Criteria:

  • Corticosteroid therapy initiated less than 7 days before study entry. Prednisone 10mgor less or equivalent is allowed. Topical or inhaled corticosteroids are permitted.
  • Secondary malignancy within 3 years of study enrollment requiring intervention exceptfor adequately treated basal, squamous cell carcinoma or non-melanomatous skin cancer,carcinoma in situ of the cervix, superficial bladder cancer not treated withintravesical chemotherapy or BCG within 6 months, localised prostate cancer and PSAstable.
  • Absolute contraindications to exercise: Recent (<6 months) acute cardiac eventunstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise,symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonaryembolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism andacute systemic infection.
  • Significant orthopaedic limitations, musculoskeletal disease and/or injury. Due to thenature of the study, persons with known joint, muscle or other orthopaedic limitationsthat restrict physical activity may be excluded.
  • Type I diabetes mellitus or uncontrolled Type II diabetes mellitus, or chronicobstructive 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

Total Participants: 132
Treatment Group(s): 2
Primary Treatment: EXE+ Nutritional Guidance
Phase:
Study Start date:
October 14, 2022
Estimated Completion Date:
August 01, 2026

Study 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.

Connect with a study center

  • University of Surrey

    Guildford, GU2 7WG
    United Kingdom

    Active - Recruiting

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