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

NCT05876923 | Recruiting

• 2 other identifiers: 22-012246NCI-2023-03210
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Assess circulating immune cell abundance and function pre-intervention

  A standardized questionnaire will be administered to assess levels of past and current physical activity. Baseline measurement of pulmonary function (PFT) will be collected and possibly a body composition scan via dual x-ray absorptiometry (DEXA). While subjects perform cardiopulmonary exercise testing (CPET), cardiopulmonary vitals will be assessed and monitored throughout exercise and in recovery. A 40 mL venous blood sample will be drawn at baseline and post exercise (80 mL total), along with finger prick measures of blood lactate at rest and early recovery. Blood samples will be evaluated to determine how circulating immune cell abundance and function (via cell counts \& cytokine profile) of chronic lymphocytic leukemia (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.

  Baseline

• Assess circulating immune cell mobilization and function post-intervention

  Each subject will participate in a 12-weeks exercise program (3 times per week) at a moderate to high exercise intensity level based upon the results of their cardiopulmonary exercise testing (CPET)\]. Upon completion of the program, subjects will return to the laboratory for post testing using the same techniques as used during the baseline. Venous blood samples drawn at rest after the program will be used to determine how circulating immune cell mobilization and function (cell counts and cytokine profile) of CLL patients respond to intervention. Usual descriptive statistics will be performed - means, standard deviations, and ranges. Comparisons within a group over time or pre/post will be performed using paired t-tests, while comparisons between groups will be performed using unpaired t-tests or where necessary using ANOVA. Comparisons will be made based on absolute values as well as changes during a test.

  Up to 12 weeks

Study Arms (5)

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

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Other: Cardiopulmonary Exercise Testing; Procedure: Dual X-ray Absorptiometry; Other: Electronic Health Record Review; Procedure: Physical Examination; Other: Questionnaire Administration; Procedure: Spirometry

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

EXPERIMENTAL

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

Procedure: Biospecimen Collection; Other: Cardiopulmonary Exercise Testing; Procedure: Dual X-ray Absorptiometry; Other: Electronic Health Record Review; Other: Exercise Intervention; Procedure: Physical Examination; Other: Questionnaire Administration; Procedure: Spirometry

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

ACTIVE COMPARATOR

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.

Procedure: Biospecimen Collection; Other: Cardiopulmonary Exercise Testing; Procedure: Dual X-ray Absorptiometry; Other: Electronic Health Record Review; Procedure: Physical Examination; Other: Questionnaire Administration; Procedure: Spirometry; Other: Physical Performance Testing; Other: Best Practice

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

ACTIVE COMPARATOR

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.

Procedure: Biospecimen Collection; Other: Cardiopulmonary Exercise Testing; Procedure: Dual X-ray Absorptiometry; Other: Electronic Health Record Review; Other: Exercise Intervention; Procedure: Physical Examination; Other: Questionnaire Administration; Procedure: Spirometry; Other: Physical Performance Testing; Other: Best Practice

Aim 5 (repeat baseline activities)

EXPERIMENTAL

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

Procedure: Biospecimen Collection; Other: Cardiopulmonary Exercise Testing; Procedure: Dual X-ray Absorptiometry; Other: Electronic Health Record Review; Procedure: Physical Examination; Other: Questionnaire Administration; Procedure: Spirometry; Other: Physical Performance Testing

Interventions

Cardiopulmonary Exercise Testing OTHER

Undergo CPET

Also known as: CPET, CPX

Aim 1 (vitals, spirometry, CPET, blood samples, DEXA); Aim 2 (aerobic based training program, Aim 1 activities); Aim 5 (repeat baseline activities); Aims 3-4 arm I (indolent NHL usual care); Aims 3-4 arm II (indolent NHL aerobic based training program)

Dual X-ray Absorptiometry PROCEDURE

Undergo DEXA scan

Also known as: 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

Aim 1 (vitals, spirometry, CPET, blood samples, DEXA); Aim 2 (aerobic based training program, Aim 1 activities); Aim 5 (repeat baseline activities); Aims 3-4 arm I (indolent NHL usual care); Aims 3-4 arm II (indolent NHL aerobic based training program)

Electronic Health Record Review OTHER

Ancillary studies

Aim 1 (vitals, spirometry, CPET, blood samples, DEXA); Aim 2 (aerobic based training program, Aim 1 activities); Aim 5 (repeat baseline activities); Aims 3-4 arm I (indolent NHL usual care); Aims 3-4 arm II (indolent NHL aerobic based training program)

Exercise Intervention OTHER

Undergo aerobic based training program

Aim 2 (aerobic based training program, Aim 1 activities); Aims 3-4 arm II (indolent NHL aerobic based training program)

Physical Examination PROCEDURE

Undergo measurement of height/weight and vital signs

Also known as: Assessment, General Examination, Physical, Physical Assessment, Physical Exam, Physical examination procedure (procedure), physical_exam

Aim 1 (vitals, spirometry, CPET, blood samples, DEXA); Aim 2 (aerobic based training program, Aim 1 activities); Aim 5 (repeat baseline activities); Aims 3-4 arm I (indolent NHL usual care); Aims 3-4 arm II (indolent NHL aerobic based training program)

Questionnaire Administration OTHER

Ancillary studies

Aim 1 (vitals, spirometry, CPET, blood samples, DEXA); Aim 2 (aerobic based training program, Aim 1 activities); Aim 5 (repeat baseline activities); Aims 3-4 arm I (indolent NHL usual care); Aims 3-4 arm II (indolent NHL aerobic based training program)

Spirometry PROCEDURE

Undergo spirometry

Aim 1 (vitals, spirometry, CPET, blood samples, DEXA); Aim 2 (aerobic based training program, Aim 1 activities); Aim 5 (repeat baseline activities); Aims 3-4 arm I (indolent NHL usual care); Aims 3-4 arm II (indolent NHL aerobic based training program)

Physical Performance Testing OTHER

Undergo muscular strength and functional endurance measurements

Also known as: Physical Fitness Testing, Physical Function Testing

Aim 5 (repeat baseline activities); Aims 3-4 arm I (indolent NHL usual care); Aims 3-4 arm II (indolent NHL aerobic based training program)

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Aims 3-4 arm I (indolent NHL usual care); Aims 3-4 arm II (indolent NHL aerobic based training program)

Biospecimen Collection PROCEDURE

Undergo collection of blood

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Aim 1 (vitals, spirometry, CPET, blood samples, DEXA); Aim 2 (aerobic based training program, Aim 1 activities); Aim 5 (repeat baseline activities); Aims 3-4 arm I (indolent NHL usual care); Aims 3-4 arm II (indolent NHL aerobic based training program)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Specimen Handling; Exercise Test; Clostridium perfringens epsilon-toxin; Absorptiometry, Photon; Bone Density; Restraint, Physical; Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; 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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Radiography; Diagnostic Imaging; Densitometry; Photometry; Chemistry Techniques, Analytical; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Behavior Control; Therapeutics; Immobilization; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Michael P. Gustafson, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Courtney Wheatley-Guy, PhD

CONTACT

480-301-8976; wheatley.courtney@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 26, 2023
• Study Start: June 12, 2023
• Primary Completion (Estimated): March 13, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (2)