Exercise for Chronic Lymphocytic Leukemia

Recruiting at 1 trial location

Overseen By Bekah McCoy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Cardiovascular disease, Pulmonary disease, Orthopedic limitations, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

70 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are receiving treatment for indolent NHL, you must have at least 8 weeks of planned treatment remaining or be at least 6 months post-treatment with no planned treatments during the 12-week intervention period.

What data supports the effectiveness of the exercise treatment for chronic lymphocytic leukemia?

Research shows that a 12-week exercise program, including high-intensity interval training and resistance training, improved muscle strength and immune function in older adults with chronic lymphocytic leukemia. This suggests that exercise can help improve physical fitness and immune response in these patients. ^{1 2 3 4 5}

Is exercise safe for people with chronic lymphocytic leukemia?

Exercise programs, including high-intensity interval training and resistance training, have been found to be safe and feasible for individuals with chronic lymphocytic leukemia and other chronic diseases. These programs can improve physical fitness and immune function without significant safety concerns. ^{1 2 6 7 8}

How does the exercise treatment for chronic lymphocytic leukemia differ from other treatments?

The exercise treatment for chronic lymphocytic leukemia is unique because it focuses on improving physical fitness and immune function through a structured program of high-intensity interval training and resistance training, rather than using medication. This approach aims to enhance muscle strength and immune cell activity, which are not typically targeted by standard drug treatments for this condition. ^{1 2 5 9 10}

Research Team

Michael P. Gustafson, Ph.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

English speaking

I am between 18 and 80 years old.

I have a confirmed diagnosis of indolent non-Hodgkin lymphoma.

Exclusion Criteria

Indolent NHL individuals receiving treatment must have at least 8 weeks of planned treatment remaining, and those not currently receiving treatment must be at least 6 months post and have no planned treatments during the 12-week intervention period to be eligible. Individuals will be excluded if they have uncontrolled hypertension, cardiac illness, or are not approved by their oncologist to participate

I do not have heart, lung diseases, or physical limitations that prevent exercise, and I have never smoked.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Aim 1: Baseline Assessment

Participants undergo measurement of height/weight and vital signs, complete lung function testing, undergo an exercise test, and collection of blood samples. Participants may also undergo DEXA scan.

1 week

1 visit (in-person)

Aim 2: Aerobic Training Program

CLL patients complete a 12-week semi-supervised aerobic training program. Patients then complete all Aim 1 activities again after completion of the program.

12 weeks

3 visits per week (in-person)

Aims 3-4: Usual Care or Aerobic Training

Indolent NHL patients undergo baseline assessments and are randomized to either usual care or a 12-week aerobic training program, followed by repeat baseline assessments.

12 weeks

Varies based on randomization

Aim 5: Follow-up

All patients from Aims 3-4 are invited to repeat baseline activities. Patients are followed up every 6 months or annually for 3 years.

3 years

Every 6 months or annually

Treatment Details

Interventions

• Exercise Intervention

Trial Overview 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.

Participant Groups

Group I: Aim 5 (repeat baseline activities) Experimental Treatment 8 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 Treatment 8 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 Treatment 7 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 Control 9 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 Control 10 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 complete aerobic based training program on study. Patients then complete all baseline activities again after completion of aerobic based training program.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

A 16-week physical activity intervention significantly improved leisure-time physical activity and reduced fatigue in patients with chronic lymphocytic leukemia (CLL), indicating potential benefits for quality of life.

The intervention was associated with favorable changes in T-cell phenotypes, including an increased CD4:CD8 T-cell ratio and a decrease in T-cell subsets linked to poor outcomes, suggesting a positive impact on immune function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationships between T-lymphocytes and physical function in adults with chronic lymphocytic leukemia: Results from the HEALTH4CLL pilot study. Crane, JC., Gordon, MJ., Basen-Engquist, K., et al.[2023]

A 12-week high-intensity interval training (HIIT) program combined with resistance training significantly improved muscle strength in older adults with chronic lymphocytic leukemia (CLL), with effect sizes indicating large improvements in leg strength (g=2.52) and chest strength (g=1.15).

The HIIT program also enhanced immune function, as evidenced by increased natural killer (NK) cell activity against tumor cells, with effect sizes of g=1.43 for K562 cells and g=1.30 for autologous B-cells, demonstrating the potential of exercise to boost immunity in CLL patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of high-intensity interval training in older adults with treatment naïve chronic lymphocytic leukemia. MacDonald, G., Sitlinger, A., Deal, MA., et al.[2022]

A systematic review of 12 studies with 812 participants found that structured exercise rehabilitation significantly improves physical function in adults undergoing treatment for hematological malignancies, with a moderate effect size (SMD = 0.39).

Multimodal exercise interventions that include both aerobic and resistance training, especially at moderate to vigorous intensities, are particularly effective in enhancing physical function during active treatment for leukemia or lymphoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Exercise Rehabilitation on Physical Function in Adults With Hematological Cancer Receiving Active Treatment: A Systematic Review and Meta-Analysis. Moore, M., Northey, JM., Crispin, P., et al.[2023]

A study involving 33 patients with acute lymphoblastic leukemia (ALL) showed that cross-training and resistance exercises significantly improved body composition and physical performance compared to a control group, which experienced muscle loss and increased fat mass.

Despite the positive effects on body composition and physical performance, the quality of life (QOL) did not show significant differences among the groups, suggesting that while exercise is beneficial for physical health, it may not directly impact overall QOL during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cross-Training and Resistance Training in Adults with Type B Acute Lymphoblastic Leukemia during the Induction Phase: A Randomized Blind Pilot Study. Gallardo-Rodríguez, AG., Fuchs-Tarlovsky, V., Ocharán-Hernández, ME., et al.[2023]

Exercise has been shown to significantly improve physical and psychological well-being in cancer patients, particularly in reducing fatigue, depression, and anxiety, as well as enhancing fitness levels during and after cancer treatment.

While exercise is feasible for patients with hematological cancers and may help alleviate treatment-related symptoms, more research is needed to determine the most effective exercise protocols for this specific group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and hematological cancer survivorship. Battaglini, CL.[2015]

A 12-week program of high-intensity interval training (HIIT) combined with resistance training (RT) significantly improved functional well-being and overall health-related quality of life in adults with chronic lymphocytic leukemia (CLL), as shown by a large effect size (Cohen's d = 1.38).

Participants in the HIIT+RT group experienced meaningful improvements in multiple quality of life measures, while the control group showed limited changes, highlighting the potential benefits of exercise interventions for individuals with CLL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of high-intensity interval training on health-related quality of life in chronic lymphocytic leukemia: A pilot study. Artese, AL., Sitlinger, A., MacDonald, G., et al.[2023]

A 12-week exercise program combining high-intensity resistance and moderate-intensity aerobic exercises significantly improved muscle strength in young patients with Acute Lymphoblastic Leukemia (ALL), with increases of up to 73% in various strength tests.

The program was safe and well-tolerated, showing no adverse effects, and while parents reported improvements in their children's quality of life, the children's self-reported quality of life did not change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a combined aerobic and strength training program in youth patients with acute lymphoblastic leukemia. Perondi, MB., Gualano, B., Artioli, GG., et al.[2021]

Exercise interventions during and after chemotherapy for patients with hematological cancer are generally reported as safe and feasible, based on a systematic review of 12 studies, including six randomized controlled trials.

Despite the positive claims about safety and feasibility, many studies lack detailed information on how these conclusions were reached, highlighting the need for more comprehensive reporting in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of exercise interventions in patients with hematological cancer undergoing chemotherapy: a systematic review. Großek, A., Großek, K., Bloch, W.[2023]

Exercise is increasingly recognized as beneficial for cancer care, particularly in improving immune function in patients with hematologic cancers, although the exact biological mechanisms are not fully understood.

A review of 7 studies indicates that exercise positively influences various immune cells and cytokines, suggesting that physical activity may enhance the immune environment in patients with hematologic malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of exercise on the immune system and outcomes in hematologic malignancies. Sitlinger, A., Brander, DM., Bartlett, DB.[2021]

A four-week nurse-led exercise intervention significantly reduced cancer-related fatigue (CRF) in leukemia patients undergoing chemotherapy, highlighting its immediate benefits.

The program also increased physical activity levels among patients, promoting their active participation in care during and after hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of a Nurse-Led Exercise Activity for Cancer-Related Fatigue in Patients With Leukemia. Galunas, L.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Relationships between T-lymphocytes and physical function in adults with chronic lymphocytic leukemia: Results from the HEALTH4CLL pilot study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A pilot study of high-intensity interval training in older adults with treatment naïve chronic lymphocytic leukemia. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of Exercise Rehabilitation on Physical Function in Adults With Hematological Cancer Receiving Active Treatment: A Systematic Review and Meta-Analysis. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Cross-Training and Resistance Training in Adults with Type B Acute Lymphoblastic Leukemia during the Induction Phase: A Randomized Blind Pilot Study. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Physical activity and hematological cancer survivorship. [2015]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of high-intensity interval training on health-related quality of life in chronic lymphocytic leukemia: A pilot study. [2023]

7. Turkey pubmed.ncbi.nlm.nih.gov

Effects of a combined aerobic and strength training program in youth patients with acute lymphoblastic leukemia. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Safety and feasibility of exercise interventions in patients with hematological cancer undergoing chemotherapy: a systematic review. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Impact of exercise on the immune system and outcomes in hematologic malignancies. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

The Impact of a Nurse-Led Exercise Activity for Cancer-Related Fatigue in Patients With Leukemia. [2022]