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

NCT ID: NCT06379282

Last Updated: 2024-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-14

Study Completion Date

2026-08-01

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Recruited participants will be randomised to either exercise only, exercise + nutritional guidance, or control for 12 weeks
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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HIT Group

Exercise Only

* 3 sessions per week
* Aerobic + Resistance Exercises

Group Type EXPERIMENTAL

HIT

Intervention Type BEHAVIORAL

Exercise training only

EXE+ Group

Exercise + Nutritional Guidance

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

Group Type EXPERIMENTAL

EXE+ Nutritional Guidance

Intervention Type BEHAVIORAL

Exercise Training + Nutritional Guidance

Control Group

Control group will receive no exercise or nutritional guidance

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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HIT

Exercise training only

Intervention Type BEHAVIORAL

EXE+ Nutritional Guidance

Exercise Training + Nutritional Guidance

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Society of Hematology

OTHER

Sponsor Role collaborator

University of Surrey

OTHER

Sponsor Role lead

Responsible Party

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David Bartlett

Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Bartlett, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Surrey

Locations

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University of Surrey

Guildford, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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David Bartlett, PhD

Role: CONTACT

01483 683 245

Ellie Miles

Role: CONTACT

01483 688 559

Facility Contacts

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David Bartlett, PhD

Role: primary

01483 683 45

Other Identifiers

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FHMS 21-22 263 EGA

Identifier Type: -

Identifier Source: org_study_id

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