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Trial Title:
Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia
NCT ID:
NCT06379282
Condition:
Chronic Lymphocytic Leukemia
Frailty
Muscle Function
Immune Function
Lipid Cell; Tumor
Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Frailty
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Recruited participants will be randomised to either exercise only, exercise + nutritional
guidance, or control for 12 weeks
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
HIT
Description:
Exercise training only
Arm group label:
HIT Group
Intervention type:
Behavioral
Intervention name:
EXE+ Nutritional Guidance
Description:
Exercise Training + Nutritional Guidance
Arm group label:
EXE+ Group
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.
Detailed 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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Surrey
Address:
City:
Guildford
Zip:
GU2 7WG
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
David Bartlett, PhD
Phone:
01483 683 45
Email:
d.bartlett@surrey.ac.uk
Start date:
October 14, 2022
Completion date:
August 1, 2026
Lead sponsor:
Agency:
University of Surrey
Agency class:
Other
Collaborator:
Agency:
American Society of Hematology
Agency class:
Other
Source:
University of Surrey
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06379282
