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The Effects of Exercise on Immune Phenotype of Indolent Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia Patients

NCT ID: NCT05876923

Last Updated: 2025-11-10

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-12

Study Completion Date

2028-04-30

Brief Summary

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This clinical trial studies the effect of short-term (acute) and long-term (chronic) exercise on immune characteristics and function (phenotype) of patients with indolent non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Most newly-diagnosed CLL patients have early-stage disease at the time of diagnosis and do not require treatment. Despite not needing therapy, these patients have significant immune dysfunction. This may lead to an increased risk of serious infections requiring hospitalization and an increased risk of secondary non-blood-based (hematologic) cancers. Increasing CLL patients overall physical fitness levels, through exercise during the observation stage, may provide a realistic approach means to increase survival, decrease treatment-related side effects, and improve immune function. Information learned from this study may help researchers determine whether a particular exercise regimen can be used to strengthen the immune system of indolent NHL and CLL patients, delay time to disease progression, assess the need for treatment, and assess infection rates.

Detailed Description

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PRIMARY OBJECTIVES:

I. Determine how circulating immune cell abundance and function (via cell counts \& cytokine profile) of CLL patients respond to acute (single bout) maximal exercise and how this differs from the response observed in group of age-matched controls by monitoring cardiopulmonary parameters and mobilization of immune cell phenotypes.

II. Determine how circulating immune cell mobilization and function (cell counts \& cytokine profile) of CLL patients respond to a 12-week semi-supervised training program of moderate to high intensity, aerobic based exercise.

III. Evaluate the effectiveness of 12-weeks of semi-supervised exercise training (ET) versus (vs.) usual care (UC) at reducing cancer-related side effects and improving quality of life (QOL) and physical fitness in individuals with indolent non-Hodgkin (NHL) lymphoma during or after treatment.

IV. Determine that extent to which 12-weeks of semi-supervised ET can modify circulating immune cell mobilization and immune function in individuals with indolent NHL during or after treatment compared to UC.

V. Development of a forward-chaining AI expert system using both manual and physiology derived feedback to optimize training results and compare its efficacy at reducing cancer-related side effects and improving quality of life (QOL) and physical fitness in individuals with indolent NHL and CLL to that of the semi-supervised ET.

OUTLINE: CLL patients and healthy participants are assigned to Aim 1. CLL patients who complete all Aim 1 activities are assigned to Aim 2. Patients with indolent NHL will be assigned to Aims 3 and 4.

AIM 1: Participants undergo measurement of height/weight and vital signs (blood pressure, temperature, heart and breathing rate), complete lung function testing (spirometry), undergo an exercise test (cardiopulmonary exercise testing \[CPET\]), and undergo collection of blood samples on study. Participants may also undergo dual X-ray absorptiometry (DEXA) scan on study.

AIM 2: CLL patients complete aerobic based training program on study. Patients then complete all Aim 1 activities again after completion of aerobic based training program.

AIMS 3-4: Indolent NHL patients undergo measurement of height/weight and vital signs (blood pressure, temperature, heart and breathing rate), complete lung function testing (spirometry), undergo an exercise test (CPET), and undergo collection of blood samples on study. Participants may also undergo DEXA scan on study. Patients undergo muscular strength and functional endurance measurements of hand grip strength, upper body power via weighted chest pass, and leg strength with the timed chair stand test and 6-minute walk test (6MWT). Patients are then randomized to 1 of 2 arms.

ARM I: Patients receive usual care on study.

ARM II: Patients complete aerobic based training program on study. Patients then complete all baseline activities again after completion of aerobic based training program.

AIM 5: All patients from Aims 3-4 will be invited to repeat Aims 3-4 baseline activities.

After completion of study intervention, patients are followed up every 6 months (Aims 2-4) or annually (Aim 5) for 3 years.

Conditions

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Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Indolent Non-hodgkin Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Aim 1 (vitals, spirometry, CPET, blood samples, DEXA)

Participants undergo measurement of height/weight and vital signs (blood pressure, temperature, heart and breathing rate), complete lung function testing (spirometry), undergo an exercise test (CPET), and undergo collection of blood samples on study. Participants may also undergo DEXA scan on study.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Cardiopulmonary Exercise Testing

Intervention Type OTHER

Undergo CPET

Dual X-ray Absorptiometry

Intervention Type PROCEDURE

Undergo DEXA scan

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Physical Examination

Intervention Type PROCEDURE

Undergo measurement of height/weight and vital signs

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Spirometry

Intervention Type PROCEDURE

Undergo spirometry

Aim 2 (aerobic based training program, Aim 1 activities)

CLL patients complete aerobic based training program on study. Patients then complete all Aim 1 activities again after completion of aerobic based training program.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Cardiopulmonary Exercise Testing

Intervention Type OTHER

Undergo CPET

Dual X-ray Absorptiometry

Intervention Type PROCEDURE

Undergo DEXA scan

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Exercise Intervention

Intervention Type OTHER

Undergo aerobic based training program

Physical Examination

Intervention Type PROCEDURE

Undergo measurement of height/weight and vital signs

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Spirometry

Intervention Type PROCEDURE

Undergo spirometry

Aims 3-4 arm I (indolent NHL usual care)

Indolent NHL patients undergo measurement of height/weight and vital signs (blood pressure, temperature, heart and breathing rate), complete lung function testing (spirometry), undergo an exercise test (CPET), and undergo collection of blood samples on study. Participants may also undergo DEXA scan on study. Patients undergo muscular strength and functional endurance measurements of hand grip strength, upper body power via weighted chest pass, and leg strength with the timed chair stand test and 6MWT. Patients receive usual care on study.

Group Type ACTIVE_COMPARATOR

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Cardiopulmonary Exercise Testing

Intervention Type OTHER

Undergo CPET

Dual X-ray Absorptiometry

Intervention Type PROCEDURE

Undergo DEXA scan

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Physical Examination

Intervention Type PROCEDURE

Undergo measurement of height/weight and vital signs

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Spirometry

Intervention Type PROCEDURE

Undergo spirometry

Physical Performance Testing

Intervention Type OTHER

Undergo muscular strength and functional endurance measurements

Best Practice

Intervention Type OTHER

Receive usual care

Aims 3-4 arm II (indolent NHL aerobic based training program)

Indolent NHL patients undergo measurement of height/weight and vital signs (blood pressure, temperature, heart and breathing rate), complete lung function testing (spirometry), undergo an exercise test (CPET), and undergo collection of blood samples on study. Participants may also undergo DEXA scan on study. Patients undergo muscular strength and functional endurance measurements of hand grip strength, upper body power via weighted chest pass, and leg strength with the timed chair stand test and 6MWT. Patients complete aerobic based training program on study. Patients then complete all baseline activities again after completion of aerobic based training program.

Group Type ACTIVE_COMPARATOR

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Cardiopulmonary Exercise Testing

Intervention Type OTHER

Undergo CPET

Dual X-ray Absorptiometry

Intervention Type PROCEDURE

Undergo DEXA scan

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Exercise Intervention

Intervention Type OTHER

Undergo aerobic based training program

Physical Examination

Intervention Type PROCEDURE

Undergo measurement of height/weight and vital signs

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Spirometry

Intervention Type PROCEDURE

Undergo spirometry

Physical Performance Testing

Intervention Type OTHER

Undergo muscular strength and functional endurance measurements

Best Practice

Intervention Type OTHER

Receive usual care

Aim 5 (repeat baseline activities)

All patients from Aims 3-4 will be invited to repeat Aims 3-4 baseline activities.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Cardiopulmonary Exercise Testing

Intervention Type OTHER

Undergo CPET

Dual X-ray Absorptiometry

Intervention Type PROCEDURE

Undergo DEXA scan

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Physical Examination

Intervention Type PROCEDURE

Undergo measurement of height/weight and vital signs

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Spirometry

Intervention Type PROCEDURE

Undergo spirometry

Physical Performance Testing

Intervention Type OTHER

Undergo muscular strength and functional endurance measurements

Interventions

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Biospecimen Collection

Undergo collection of blood

Intervention Type PROCEDURE

Cardiopulmonary Exercise Testing

Undergo CPET

Intervention Type OTHER

Dual X-ray Absorptiometry

Undergo DEXA scan

Intervention Type PROCEDURE

Electronic Health Record Review

Ancillary studies

Intervention Type OTHER

Exercise Intervention

Undergo aerobic based training program

Intervention Type OTHER

Physical Examination

Undergo measurement of height/weight and vital signs

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Spirometry

Undergo spirometry

Intervention Type PROCEDURE

Physical Performance Testing

Undergo muscular strength and functional endurance measurements

Intervention Type OTHER

Best Practice

Receive usual care

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection CPET CPX BMD scan bone mineral density scan DEXA DEXA (Bone Density) DEXA Scan dual energy x-ray absorptiometric scan Dual Energy X-ray Absorptiometry Dual X-Ray Absorptometry DXA DXA SCAN Assessment General Examination Physical Physical Assessment Physical Exam Physical examination procedure (procedure) physical_exam Physical Fitness Testing Physical Function Testing standard of care standard therapy

Eligibility Criteria

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Inclusion Criteria

* English speaking
* Between the ages of 18-80
* Histologically confirmed diagnosis of indolent non-Hodgkin lymphoma (NHL) will be required to participate in Aim 2 (CLL/SLL only), aim 3 and 4 (indolent NHL) and aim 5 (indolent NHL) of this study

Exclusion Criteria

* Healthy subjects participating in Aim 1 will be excluded if they have known cardiovascular or pulmonary disease (e.g. heart disease, coronary artery disease, chronic obstructive pulmonary disease \[COPD\], asthma, etc.) an orthopedic or musculoskeletal limitation which would limit ability to exercise or are a current or former smoker
* Indolent NHL individuals receiving treatment must have least 8 weeks of planned treatment remaining and those who have already received treatment must be at least 6 months post and have no planned treatments during the 12-week intervention period to be eligible. Individuals that are participating prior to receiving treatment must not have any scheduled treatments during their participation. Individuals will be excluded if they have uncontrolled hypertension, cardiac illness, or are not approved by their oncologist to participate
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael P. Gustafson, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Trials Referral Office

Role: CONTACT

Phone: 855-776-0015

Email: [email protected]

Courtney Wheatley-Guy, PhD

Role: CONTACT

Phone: 480-301-8976

Email: [email protected]

Facility Contacts

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Clinical Trials Referral Office

Role: primary

Jordan Parks

Role: backup

Clinical Trials Referral Office

Role: primary

Briana Ziegler

Role: backup

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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NCI-2023-03210

Identifier Type: REGISTRY

Identifier Source: secondary_id

22-012246

Identifier Type: OTHER

Identifier Source: secondary_id

22-012246

Identifier Type: -

Identifier Source: org_study_id