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UNKNOWNNA

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

Sponsor: University of Surrey

NCT ID: NCT06379282

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
HIT (behavioural), EXE+ Nutritional Guidance (behavioural)
How long the study runs
Study runs about 46 months (dates as stated)
About the drug or intervention
HIT — behavioural: Exercise training only · EXE+ Nutritional Guidance — behavioural: Exercise Training + Nutritional Guidance
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
132
Started
2022-10-14
Last checked
2024-04

Plain English Summary

What is this study?

  • • Testing a new treatment for chronic lymphocytic leukemia
  • • NA - 132 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with chronic lymphocytic leukemia

Where?

  • • Guildford - University of Surrey

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

More detail

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.

Chronic Lymphocytic LeukemiaFrailtyMuscle FunctionImmune FunctionLipid Cell; Tumor

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What we know so far

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

PSA

What the study is looking for

  • ✓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+)

Who cannot take part

  • ✗Corticosteroid therapy initiated less than 7 days before study entry. Prednisone 10mg or less or equivalent is...
  • ✗Type I diabetes mellitus or uncontrolled Type II diabetes mellitus, or chronic obstructive lung disease
  • ✗Uncontrolled blood pressure (≥180/90) at rest
  • ✗Known concurrent HIV, Hepatitis B or Hepatitis C
  • ✗Unable to comply with other study requirements
See the full 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 Is This Study? (1 UK site)

University of Surrey

Guildford GU2 7WG, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

David Bartlett, PhD

Sponsor contact

CONTACT

01483 683 245 d.bartlett@surrey.ac.uk

Ellie Miles

Sponsor contact

CONTACT

01483 688 559 e.e.miles@surrey.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-04