Trial Title:
The Effects of Acute and Chronic Exercise on Immune Phenotype of Indolent Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia Patients
NCT ID:
NCT05876923
Condition:
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Indolent Non-hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Leukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood
Arm group label:
Aim 1 (vitals, spirometry, CPET, blood samples, DEXA)
Arm group label:
Aim 2 (aerobic based training program, Aim 1 activities)
Arm group label:
Aim 5 (repeat baseline activities)
Arm group label:
Aims 3-4 arm I (indolent NHL usual care)
Arm group label:
Aims 3-4 arm II (indolent NHL aerobic based training program)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Cardiopulmonary Exercise Testing
Description:
Undergo CPET
Arm group label:
Aim 1 (vitals, spirometry, CPET, blood samples, DEXA)
Arm group label:
Aim 2 (aerobic based training program, Aim 1 activities)
Arm group label:
Aim 5 (repeat baseline activities)
Arm group label:
Aims 3-4 arm I (indolent NHL usual care)
Arm group label:
Aims 3-4 arm II (indolent NHL aerobic based training program)
Other name:
CPET
Other name:
CPX
Intervention type:
Procedure
Intervention name:
Dual X-ray Absorptiometry
Description:
Undergo DEXA scan
Arm group label:
Aim 1 (vitals, spirometry, CPET, blood samples, DEXA)
Arm group label:
Aim 2 (aerobic based training program, Aim 1 activities)
Arm group label:
Aim 5 (repeat baseline activities)
Arm group label:
Aims 3-4 arm I (indolent NHL usual care)
Arm group label:
Aims 3-4 arm II (indolent NHL aerobic based training program)
Other name:
BMD scan
Other name:
bone mineral density scan
Other name:
DEXA
Other name:
DEXA (Bone Density)
Other name:
DEXA Scan
Other name:
dual energy x-ray absorptiometric scan
Other name:
Dual Energy X-ray Absorptiometry
Other name:
Dual X-Ray Absorptometry
Other name:
DXA
Other name:
DXA SCAN
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Aim 1 (vitals, spirometry, CPET, blood samples, DEXA)
Arm group label:
Aim 2 (aerobic based training program, Aim 1 activities)
Arm group label:
Aim 5 (repeat baseline activities)
Arm group label:
Aims 3-4 arm I (indolent NHL usual care)
Arm group label:
Aims 3-4 arm II (indolent NHL aerobic based training program)
Intervention type:
Other
Intervention name:
Exercise Intervention
Description:
Undergo aerobic based training program
Arm group label:
Aim 2 (aerobic based training program, Aim 1 activities)
Arm group label:
Aims 3-4 arm II (indolent NHL aerobic based training program)
Intervention type:
Procedure
Intervention name:
Physical Examination
Description:
Undergo measurement of height/weight and vital signs
Arm group label:
Aim 1 (vitals, spirometry, CPET, blood samples, DEXA)
Arm group label:
Aim 2 (aerobic based training program, Aim 1 activities)
Arm group label:
Aim 5 (repeat baseline activities)
Arm group label:
Aims 3-4 arm I (indolent NHL usual care)
Arm group label:
Aims 3-4 arm II (indolent NHL aerobic based training program)
Other name:
Assessment
Other name:
General Examination
Other name:
Physical
Other name:
Physical Assessment
Other name:
Physical Exam
Other name:
Physical examination procedure (procedure)
Other name:
physical_exam
Intervention type:
Other
Intervention name:
Quality-of-Life Assessment
Description:
Ancillary studies
Arm group label:
Aim 1 (vitals, spirometry, CPET, blood samples, DEXA)
Arm group label:
Aim 2 (aerobic based training program, Aim 1 activities)
Arm group label:
Aim 5 (repeat baseline activities)
Arm group label:
Aims 3-4 arm I (indolent NHL usual care)
Arm group label:
Aims 3-4 arm II (indolent NHL aerobic based training program)
Other name:
Quality of Life Assessment
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Aim 1 (vitals, spirometry, CPET, blood samples, DEXA)
Arm group label:
Aim 2 (aerobic based training program, Aim 1 activities)
Arm group label:
Aim 5 (repeat baseline activities)
Arm group label:
Aims 3-4 arm I (indolent NHL usual care)
Arm group label:
Aims 3-4 arm II (indolent NHL aerobic based training program)
Intervention type:
Procedure
Intervention name:
Spirometry
Description:
Undergo spirometry
Arm group label:
Aim 1 (vitals, spirometry, CPET, blood samples, DEXA)
Arm group label:
Aim 2 (aerobic based training program, Aim 1 activities)
Arm group label:
Aim 5 (repeat baseline activities)
Arm group label:
Aims 3-4 arm I (indolent NHL usual care)
Arm group label:
Aims 3-4 arm II (indolent NHL aerobic based training program)
Intervention type:
Other
Intervention name:
Physical Performance Testing
Description:
Undergo muscular strength and functional endurance measurements
Arm group label:
Aim 5 (repeat baseline activities)
Arm group label:
Aims 3-4 arm I (indolent NHL usual care)
Arm group label:
Aims 3-4 arm II (indolent NHL aerobic based training program)
Other name:
Physical Fitness Testing
Other name:
Physical Function Testing
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive usual care
Arm group label:
Aims 3-4 arm I (indolent NHL usual care)
Arm group label:
Aims 3-4 arm II (indolent NHL aerobic based training program)
Other name:
standard of care
Other name:
standard therapy
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Recruiting
Contact:
Last name:
Courtney M. Wheatley-Guy, M.D., Ph.D.
Phone:
480-301-6616
Email:
wheatley.courtney@mayo.edu
Investigator:
Last name:
Michael P. Gustafson, Ph.D.
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Neil E. Kay, M.D.
Email:
Principal Investigator
Start date:
March 13, 2023
Completion date:
April 2028
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05876923
https://www.mayo.edu/research/clinical-trials
