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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT05876923
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood
  • Cardiopulmonary Exercise Testing — OTHER
    Undergo CPET
  • Dual X-ray Absorptiometry — PROCEDURE
    Undergo DEXA scan
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Exercise Intervention — OTHER
    Undergo aerobic based training program
  • Physical Examination — PROCEDURE
    Undergo measurement of height/weight and vital signs
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Spirometry — PROCEDURE
    Undergo spirometry
  • Physical Performance Testing — OTHER
    Undergo muscular strength and functional endurance measurements
  • Best Practice — OTHER
    Receive usual care

Study Details

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.

Key Dates

Start date
Jun 12, 2023
Status verified
Apr 2026
Primary completion
Mar 13, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Active Comparator: 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.
  • Active Comparator: 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.
  • Experimental: Aim 5 (repeat baseline activities)
    All patients from Aims 3-4 will be invited to repeat Aims 3-4 baseline activities.

Primary Outcome Measure

Assess circulating immune cell abundance and function pre-intervention [ Time Frame: Baseline ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Clinical Trials Referral Office
[email protected]
855-776-0015
Jordan Parks
[email protected]
480-301-6616
Michael P. Gustafson, PhD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Briana Ziegler
[email protected]
507-255-7125
Neil E. Kay, M.D. (PRINCIPAL_INVESTIGATOR)

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