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

Primary Purpose

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biospecimen Collection
Cardiopulmonary Exercise Testing
Dual X-ray Absorptiometry
Electronic Health Record Review
Exercise Intervention
Physical Examination
Quality-of-Life Assessment
Questionnaire Administration
Spirometry
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo Clinic in Arizona
  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Aim 1 (vitals, spirometry, CPET, blood samples, DEXA)

Aim 2 (aerobic based training program, Aim 1 activities)

Arm Description

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.

CLL patients complete aerobic based training program on study. Patients then complete all Aim 1 activities again after completion of aerobic based training program.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 1, 2023
Last Updated
July 3, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05876923
Brief Title
The Effects of Acute and Chronic Exercise on the Immune Phenotype of Chronic Lymphocytic Leukemia Patients
Official Title
The Effects of Acute and Chronic Exercise on the Immune Phenotype of Chronic Lymphocytic Leukemia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Suspended
Why Stopped
Number of patients interested in participating has exceeded the number of patients we have funding for.
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
March 13, 2028 (Anticipated)
Study Completion Date
April 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aim 1 (vitals, spirometry, CPET, blood samples, DEXA)
Arm Type
Experimental
Arm Description
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.
Arm Title
Aim 2 (aerobic based training program, Aim 1 activities)
Arm Type
Experimental
Arm Description
CLL patients complete aerobic based training program on study. Patients then complete all Aim 1 activities again after completion of aerobic based training program.
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection, Biospecimen Collected, Specimen Collection
Intervention Description
Undergo collection of blood
Intervention Type
Other
Intervention Name(s)
Cardiopulmonary Exercise Testing
Other Intervention Name(s)
CPET, CPX
Intervention Description
Undergo CPET
Intervention Type
Procedure
Intervention Name(s)
Dual X-ray Absorptiometry
Other Intervention Name(s)
BMD scan, bone mineral density scan, DEXA, DEXA (Bone Density), DEXA Scan, dual energy x-ray absorptiometric scan, Dual Energy X-ray Absorptiometry, Dual X-Ray Absorptometry, DXA, DXA SCAN
Intervention Description
Undergo DEXA scan
Intervention Type
Other
Intervention Name(s)
Electronic Health Record Review
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
Undergo aerobic based training program
Intervention Type
Procedure
Intervention Name(s)
Physical Examination
Other Intervention Name(s)
Assessment, General Examination, Physical, Physical Assessment, Physical Exam, Physical examination procedure (procedure), physical_exam
Intervention Description
Undergo measurement of height/weight and vital signs
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Spirometry
Intervention Description
Undergo spirometry
Primary Outcome Measure Information:
Title
Assess circulating immune cell abundance and function pre-intervention
Description
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
Baseline
Title
Assess circulating immune cell mobilization and function post-intervention
Description
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 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael P Gustafson
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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