Chronic Lymphocytic LeukemiaHIT-CLLNCT06379282
Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia
A study testing HIT and EXE+ Nutritional Guidance in people with Chronic Lymphocytic Leukemia and Frailty, run by University of Surrey at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Frailty, Muscle Function
- What is being tested?
- HIT and EXE+ Nutritional Guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Oct 2022to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Surrey
Guildford, GU2 7WG
David Bartlett, PhD, 01483 683 45, d.bartlett@surrey.ac.uk
About this study
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.
Read the 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.
- Conditions
- Chronic Lymphocytic Leukemia, Frailty, Muscle Function, Immune Function, Lipid Cell; Tumor
- Being tested
- HIT, EXE+ Nutritional Guidance
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Frailty, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HITBehavioural
Exercise training only
EXE+ Nutritional GuidanceBehavioural
Exercise Training + Nutritional Guidance
| Study group | Role | What they receive |
|---|---|---|
| HIT Group | Experimental | Exercise Only
* 3 sessions per week
* Aerobic + Resistance Exercises Receives: 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 Receives: Behavioral: EXE+ Nutritional Guidance |
| Control Group | No intervention | Control group will receive no exercise or nutritional guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline and 12 weeks
Secondary outcomes (7)
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)
Measured: Baseline and 12 weeks
Muscle Strength and Endurance
Estimated one repetition maximum and repetitions to failure using machine-based weights
Measured: Baseline and 12 weeks
Muscle Health
Ultrasound and near-infrared spectroscopy assessment of muscle fuel usage
Measured: Baseline and 12 weeks
Change in Quality of Life using the EORCT-QLQ-C30
Quality of life will be determined by the EORCT-QLQ-C30 questionnaire
Measured: Baseline and 12 weeks
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
Measured: Baseline and 12 weeks
Change in B-CLL Cell Function
Measurement of in vitro B-CLL cell proliferation by flow cytometry
Measured: Baseline and 12 weeks
Change in systemic and cellular bioenergetics
Measurement of in vitro immune cell fuel utilisation by high resolution respirometry and mass spectrometry
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start14 Oct 2022
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Recruited participants will be randomised to either exercise only, exercise + nutritional guidance, or control for 12 weeks
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Hematology
- Responsible party
- Principal investigator, David Bartlett, University of Surrey
- Investigators
- David Bartlett, PhD, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379282
- Sponsor's protocol ID
- FHMS 21-22 263 EGA
- Acronym
- HIT-CLL
- Status last verified
- Apr 2024
- First submitted
- 9 Feb 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia
- ClinicalTrials.gov ID
- NCT06379282
- Acronym / sponsor ID
- HIT-CLL / FHMS 21-22 263 EGA
- Conditions
- Chronic Lymphocytic Leukemia, Frailty, Muscle Function, Immune Function, Lipid Cell; Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- American Society of Hematology
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Recruited participants will be randomised to either exercise only, exercise + nutritional guidance, or control for 12 weeks
| Arm | Type | Receives |
|---|---|---|
| HIT Group | Experimental | Behavioral: HITExercise Only * 3 sessions per week * Aerobic + Resistance Exercises |
| EXE+ Group | Experimental | Behavioral: EXE+ Nutritional GuidanceExercise + Nutritional Guidance * 3 sessions per week * Aerobic + Resistance Exercises * Dietary assessment at baseline and during with guidance on eating a healthy diet provided |
| Control Group | No intervention | –Control group will receive no exercise or nutritional guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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+)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HITExercise training only | Behavioural | HIT Group |
| EXE+ Nutritional GuidanceExercise Training + Nutritional Guidance | Behavioural | EXE+ Group |
Primary outcome
Change from baseline in absolute number of CD19+/CD5+ CLL cells at week 12
Time frame: Baseline and 12 weeks
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
Change from baseline in cardiorespiratory fitness (CRF: VO2peak) at week 12
Time frame: Baseline and 12 weeks
Cardiopulmonary exercise testing will be conducted to assess changes in fitness
7 secondary outcomes
Frailty
Time frame: Baseline and 12 weeks
Muscle Strength and Endurance
Time frame: Baseline and 12 weeks
Muscle Health
Time frame: Baseline and 12 weeks
Change in Quality of Life using the EORCT-QLQ-C30
Time frame: Baseline and 12 weeks
Change in muscle oxygen metabolism during a single bout of exercise
Time frame: Baseline and 12 weeks
Change in B-CLL Cell Function
Time frame: Baseline and 12 weeks
Change in systemic and cellular bioenergetics
Time frame: Baseline and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Bartlett, PhD principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIT and EXE+ Nutritional Guidance in people with Chronic Lymphocytic Leukemia and Frailty, run by University of Surrey at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Bartlett, PhD (01483 683 245, d.bartlett@surrey.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in absolute number of CD19+/CD5+ CLL cells at week 12 (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.