Chronic Lymphocytic Leukemia Clinical Trial

The Effects of Acute and Chronic Exercise on the Immune Phenotype of Chronic Lymphocytic Leukemia Patients

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 leukemia-cll/" >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 CLL patients, delay time to disease progression, assess the need for treatment, and assess infection rates.

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Full Description

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.

OUTLINE: CLL patients and healthy participants are assigned to Aim 1. CLL patients who complete all Aim 1 activities are assigned to Aim 2.

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.

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Eligibility Criteria

Inclusion Criteria:

18-80 years of age will participate in this study
Diagnosis of CLL/SLL (chronic lymphocytic leukemia/small lymphocytic lymphoma) will be required to participate in Aim 2 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

Study is for people with:

Chronic Lymphocytic Leukemia

Estimated Enrollment:

100

Study ID:

NCT05876923

Recruitment Status:

Recruiting

Sponsor:

Mayo Clinic

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There are 2 Locations for this study

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Mayo Clinic in Arizona
Scottsdale Arizona, 85259, United States More Info
Michael P. Gustafson
Contact
480-342-4578
[email protected]
Michael P. Gustafson
Principal Investigator
Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States More Info
Neil E. Kay
Contact
507-284-4441
[email protected]
Neil E. Kay
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Estimated Enrollment:

100

Study ID:

NCT05876923

Recruitment Status:

Recruiting

Sponsor:


Mayo Clinic

How clear is this clinincal trial information?

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