Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Indolent Non-hodgkin Lymphoma
Conditions
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.
Detailed 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. 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.
Interventions
PROCEDUREBiospecimen Collection
Undergo collection of blood
OTHERCardiopulmonary Exercise Testing
Undergo CPET
PROCEDUREDual X-ray Absorptiometry
Undergo DEXA scan
OTHERElectronic Health Record Review
Ancillary studies
OTHERExercise Intervention
Undergo aerobic based training program
PROCEDUREPhysical Examination
Undergo measurement of height/weight and vital signs
OTHERQuestionnaire Administration
Ancillary studies
PROCEDURESpirometry
Undergo spirometry
OTHERPhysical Performance Testing
Undergo muscular strength and functional endurance measurements
OTHERBest Practice
Receive usual care
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess circulating immune cell abundance and function pre-intervention | Baseline | 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. |
| Assess circulating immune cell mobilization and function post-intervention | Up to 12 weeks | 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. |
Countries
United States
Contacts
Primary ContactClinical Trials Referral Office
Backup ContactCourtney Wheatley-Guy, PhD
Outcome results
None listed