The Effects of Exercise on Immune Phenotype of Indolent Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood
Cardiopulmonary Exercise Testing
Other interventionUndergo CPET
Dual X-ray Absorptiometry
Procedure/SurgeryUndergo DEXA scan
Electronic Health Record Review
Other interventionAncillary studies
Exercise Intervention
Other interventionUndergo aerobic based training program
Physical Examination
Procedure/SurgeryUndergo measurement of height/weight and vital signs
Questionnaire Administration
Other interventionAncillary studies
Spirometry
Procedure/SurgeryUndergo spirometry
Physical Performance Testing
Other interventionUndergo muscular strength and functional endurance measurements
Best Practice
Other interventionReceive usual care
Treatment groups
70 Participants
are divided into 5 treatment groupsGroup A: Aim 1 (vitals, spirometry, CPET, blood samples, DEXA)Experimental treatment 7 interventions
Group B: Aim 2 (aerobic based training program, Aim 1 activities)Experimental treatment 8 interventions
Group C: Aims 3-4 arm I (indolent NHL usual care)Active comparator 9 interventions
Group D: Aims 3-4 arm II (indolent NHL aerobic based training program)Active comparator 10 interventions
Group E: Aim 5 (repeat baseline activities)Experimental treatment 8 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
Up to 12 weeksSponsors and contacts
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Source ClinicalTrials.gov