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Exercise for Chronic Lymphocytic Leukemia

N/A

Recruiting

Led By Michael P Gustafson

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how exercise affects the immune system of CLL patients to improve survival, reduce side effects, and strengthen their immune system.

Who is the study for?

This trial is for people aged 18-80 with indolent non-Hodgkin lymphoma or chronic lymphocytic leukemia. Participants should be in the early stages of their disease and not currently require treatment, but have immune dysfunction that could benefit from improved physical fitness.

What is being tested?

The study tests how both short-term and long-term exercise regimens affect the immune system's characteristics and functions in patients with certain types of blood cancers. It aims to see if exercise can boost immunity, delay disease progression, reduce infection rates, and lessen the need for treatments.

What are the potential side effects?

Since this trial involves exercise interventions rather than medication, side effects may include typical exercise-related issues such as muscle soreness or strain. The intensity of these will vary based on individual fitness levels and health status.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess circulating immune cell abundance and function pre-intervention

Assess circulating immune cell mobilization and function post-intervention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Aim 5 (repeat baseline activities)Experimental Treatment9 Interventions

All patients from Aims 3-4 will be invited to repeat Aims 3-4 baseline activities.

Group II: Aim 2 (aerobic based training program, Aim 1 activities)Experimental Treatment9 Interventions

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

Group III: Aim 1 (vitals, spirometry, CPET, blood samples, DEXA)Experimental Treatment8 Interventions

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.

Group IV: Aims 3-4 arm I (indolent NHL usual care)Active Control10 Interventions

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 6MWT. Patients receive usual care on study.

Group V: Aims 3-4 arm II (indolent NHL aerobic based training program)Active Control11 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Physical Examination

2019

Completed Phase 1

~1200

Biospecimen Collection

2004

Completed Phase 3