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

NCT06379282 | Recruiting

• 1 other identifier: FHMS 21-22 263 EGA
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Lymphocytic Leukemia; Frailty; Muscle Function; Immune Function; Lipid Cell; Tumor

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Frailty

  Baseline and 12 weeks

• Muscle Strength and Endurance

  Baseline and 12 weeks

• Muscle Health

  Baseline and 12 weeks

• Change in Quality of Life using the EORCT-QLQ-C30

  Baseline and 12 weeks

• Change in muscle oxygen metabolism during a single bout of exercise

  Baseline and 12 weeks

Other Outcomes (2)

• Legacy Effect of Intervention on change in cardiorespiratory fitness (VO2peak) as measured by a cardiopulmonary exercise test

  12 weeks to 24 weeks

• Legacy Effect of Intervention on absolute number of CD19+/CD5+ CLL cells

  12 weeks to 24 weeks

Study Arms (3)

HIT Group

EXPERIMENTAL

Exercise Only * 3 sessions per week * Aerobic + Resistance Exercises

Behavioral: HIT

EXE+ Group

EXPERIMENTAL

Exercise + Nutritional Guidance * 3 sessions per week * Aerobic + Resistance Exercises * Dietary assessment at baseline and during with guidance on eating a healthy diet provided

Behavioral: EXE+ Nutritional Guidance

Control Group

NO INTERVENTION

Control group will receive no exercise or nutritional guidance

Interventions

HIT BEHAVIORAL

Exercise training only

HIT Group

EXE+ Nutritional Guidance BEHAVIORAL

Exercise Training + Nutritional Guidance

EXE+ Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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+)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Surrey: lead
• American Society of Hematology: collaborator

Study Sites (1)

University of Surrey

Guildford, GU2 7WG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Frailty; Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Bartlett, PhD

  University of Surrey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Bartlett, PhD

CONTACT

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

Ellie Miles

CONTACT

01483 688 559; e.e.miles@surrey.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: Recruited participants will be randomised to either exercise only, exercise + nutritional guidance, or control for 12 weeks

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: April 23, 2024
• Study Start: October 14, 2022
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)