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

Chronic Lymphocytic Leukemia Clinical Trial

— HIT-CLL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06379282
• Other study ID #: FHMS 21-22 263 EGA
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2022
• Est. completion date: August 1, 2026

Study information

• Verified date: April 2024
• Source: University of Surrey
• Contact: David Bartlett, PhD
• Phone: 01483 683 245
• Email: d.bartlett[@]surrey.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Frailty
• Immune Function
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Muscle Function

Intervention

Behavioral:
• HIT
Exercise training only
• EXE+ Nutritional Guidance
Exercise Training + Nutritional Guidance

Locations

Country	Name	City	State
United Kingdom	University of Surrey	Guildford

Sponsors (2)

Lead Sponsor	Collaborator
University of Surrey	American Society of Hematology

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	12 weeks to 24 weeks
Other	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	12 weeks to 24 weeks
Primary	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	Baseline and 12 weeks
Primary	Change from baseline in cardiorespiratory fitness (CRF: VO2peak) at week 12	Cardiopulmonary exercise testing will be conducted to assess changes in fitness	Baseline and 12 weeks
Secondary	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)	Baseline and 12 weeks
Secondary	Muscle Strength and Endurance	Estimated one repetition maximum and repetitions to failure using machine-based weights	Baseline and 12 weeks
Secondary	Muscle Health	Ultrasound and near-infrared spectroscopy assessment of muscle fuel usage	Baseline and 12 weeks
Secondary	Change in Quality of Life using the EORCT-QLQ-C30	Quality of life will be determined by the EORCT-QLQ-C30 questionnaire	Baseline and 12 weeks
Secondary	Change in muscle oxygen metabolism during a single bout of exercise	Measurement of muscle oxygenation via near infrared spectroscopy during a single session of acute exercise	Baseline and 12 weeks
Secondary	Change in B-CLL Cell Function	Measurement of in vitro B-CLL cell proliferation by flow cytometry	Baseline and 12 weeks
Secondary	Change in systemic and cellular bioenergetics	Measurement of in vitro immune cell fuel utilisation by high resolution respirometry and mass spectrometry	Baseline and 12 weeks