Exercise for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Michael P Gustafson

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

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

No Placebo Group

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}

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.

Trial 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

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic in Arizona Scottsdale, AZ

Mayo Clinic in Rochester Rochester, MN

Who Is Running the Clinical Trial?

Mayo Clinic Lead Sponsor

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] Examine physical function and T-cell phenotype in patients with chronic lymphocytic leukemia (CLL) before and after a physical activity (PA) intervention.

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] Chronic lymphocytic leukemia (CLL) is the most common leukemia in the USA, affecting predominantly older adults. CLL is characterized by low physical fitness, reduced immunity, and increased risk of secondary malignancies and infections. One approach to improving CLL patients' physical fitness and immune functions may be participation in a structured exercise program. The aims of this pilot study were to examine physical and immunological changes, and feasibility of a 12-week high-intensity interval training (HIIT) combined with muscle endurance-based resistance training on older adults with treatment naïve CLL. We enrolled eighteen participants with CLL aged 64.9 ± 9.1 years and assigned them to groups depending on distance lived from our fitness center. Ten participants (4 M/6F) completed HIIT and six participants (4 M/2F) completed a non-exercising control group (Controls). HIIT consisted of three 30-min treadmill sessions/week plus two concurrent 30-min strength training sessions/week. Physical and immunological outcomes included aerobic capacity, muscle strength and endurance, and natural killer (NK) cell recognition and killing of tumor cells. We confirmed feasibility if > 70% of HIIT participants completed > 75% of prescribed sessions and prescribed minutes, and if > 80% of high-intensity intervals were at a heart rate corresponding to at least 80% of peak aerobic capacity (VO2peak). Results are presented as Hedge's G effect sizes (g), with 0.2, 0.5 and 0.8 representing small, medium and large effects, respectively. Following HIIT, leg strength (g = 2.52), chest strength (g = 1.15) and seated row strength (g = 3.07) were 35.4%, 56.1% and 39.5% higher than Controls, respectively, while aerobic capacity was 3.8% lower (g = 0.49) than Controls. Similarly, following HIIT, in vitro NK-cell cytolytic activity against the K562 cell line (g = 1.43), OSU-CLL cell line (g = 0.95), and autologous B-cells (g = 1.30) were 20.3%, 3.0% and 14.6% higher than Controls, respectively. Feasibility was achieved, with HIIT completing 5.0 ± 0.2 sessions/week and 99 ± 3.6% of the prescribed minutes/week at heart rates corresponding to 89 ± 2.8% of VO2peak. We demonstrate that 12-weeks of supervised HIIT combined with muscle endurance-based resistance training is feasible, and that high adherence and compliance are associated with large effects on muscle strength and immune function in older adults with treatment naïve CLL.Trial registration: NCT04950452.

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] Evaluate the efficacy of exercise rehabilitation at improving physical function during active treatment for adults diagnosed with a hematological malignancy.

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] Patients with acute lymphoblastic leukemia (ALL) undergoing induction decrease their physical capacity, lose muscle mass, and decrease their quality of life (QOL). The safety, feasibility, and benefits of exercise during chemotherapy have been proven, but the effects of cross-training activities have yet to be analyzed. To measure the effects of cross-training on body composition, physical performance, and QOL, a blind randomized clinical trial was carried out. A total of 33 patients were included and randomized into a cross-training exercise group (CEG), a resistance exercise group (REG), and a control group (CG). During induction, patients received an exercise routine three to five days a week for 30 to 50 min each. Body composition, QOL, and physical performance were measured at baseline, up to discharge, and at a follow-up of two months. Body composition improved in the REG and CEG. In the CG, muscle mass decreased and fat mass increased (p = 0.020 and 0.020, respectively). The REG and CEG had significant positive improvements in physical performance compared to the CG. QOL showed no differences in any group (p = 0.340). Cross-training and resistance exercise are essential to improve body composition and physical performance during induction. Considering the prognostic value of physical performance, we propose integrated training exercises as adjuvant therapy in adult patients with ALL.

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

Physical activity and hematological cancer survivorship. [2015] As previously presented in other chapters of this book, exercise has been shown through large scale studies to be associated with significant improvements in physical and psychological parameters in patients with one of several different tumor types (Galvao et al. 2010; Schwartz and Winters-Stone 2009; Galvao et al. 2009; Segal et al. 2009; Courneya et al. 2008a, b; Ligibel et al. 2008; Courneya et al. 2007; Schmitz et al. 2005a; Fairey et al. 2005). In addition, well conducted systematic reviews of the literature that have explored the effects of exercise before, during, or after anticancer therapy have consistently shown positive outcomes to patients treated for solid tumors. Consistent findings include an overall reduction in fatigue, depression, anxiety, and distress, paired with positive changes in fitness parameters such as aerobic capacity and overall muscle function (Speck et al. 2010; Jones et al. 2006; McNeely et al. 2006; Markes et al. 2006; Schmitz et al. 2005; Galvao and Newton 2005). However, a relative paucity of data exists in the area of exercise interventions for adult patients with hematological malignancies. This chapter reviews the current literature regarding the administration of exercise in adult patients diagnosed with hematological cancer. The few exercise intervention studies conducted in patients with hematological cancers suggest that it is feasible to administer exercise to most patients and that exercise should be considered as an intervention to alleviate treatment-related symptoms. Yet, efficacy along with the appropriate mode, intensity, and frequency of exercise training in different types of hematological cancers are yet to be established and require further research.

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] Chronic lymphocytic leukemia (CLL) is the most common incurable leukemia/lymphoma in the United States. Individuals with CLL are at risk for disability, frailty, and cancer-specific complications that negatively affect health-related quality of life (HRQOL). High-intensity interval training (HIIT) and resistance training (RT) are safe and feasible for individuals with chronic diseases and when combined, they may be beneficial for reducing cancer-related fatigue, symptom burden, and global quality of life. However, no studies have examined the impact of HIIT or RT on HRQOL in CLL. The purpose of this study was to investigate the effects of a 12-week HIIT and RT (HIIT+RT) intervention on HRQOL in adults with treatment naïve CLL.

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

Effects of a combined aerobic and strength training program in youth patients with acute lymphoblastic leukemia. [2021] Cure rates of youth with Acute Lymphoblastic Leukemia (ALL) have increased in the past decades, but survivor's quality of life and physical fitness has become a growing concern. Although previous reports showed that resistance training is feasible and effective, we hypothesized that a more intense exercise program would also be feasible, but more beneficial than low- to moderate-intensity training programs. We aimed to examine the effects of an exercise program combining high-intensity resistance exercises and moderate-intensity aerobic exercises in young patients undergoing treatment for ALL. A quasi-experimental study was conducted. The patients (n = 6; 5-16 years of age) underwent a 12-week intra-hospital training program involving high-intensity strength exercises and aerobic exercise at 70% of the peak oxygen consumption. At baseline and after 12 weeks, we assessed sub-maximal strength (10 repetition-maximum), quality of life and possible adverse effects. A significant improvement was observed in the sub maximal strength for bench press (71%), lat pull down (50%), leg press (73%) and leg extension (64%) as a result of the training (p

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

Safety and feasibility of exercise interventions in patients with hematological cancer undergoing chemotherapy: a systematic review. [2023] Exercise during and after cancer treatment has established quality of life and health benefits. However, particularly for patients with hematological cancer clear recommendations regarding the safety and feasibility of exercise are under-investigated. The aim of our systematic review was to summarize the literature regarding the feasibility and safety of exercise interventions in patients diagnosed with hematological cancer undergoing chemotherapy.

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

Impact of exercise on the immune system and outcomes in hematologic malignancies. [2021] Exercise is increasingly recognized as important to cancer care. The biology of how exercise improves outcomes is not well understood, however. Studies show that exercise favorably influences the immune system in healthy individuals (neutrophils, monocytes, natural killer cells, T cells, and a number of cytokines). Thus, exercise in patients with hematologic cancer could significantly improve immune function and tumor microenvironment. We performed a literature search and identified 7 studies examining exercise and the immune environment in hematologic malignancies. This review focuses on the role of exercise and physical activity on the immune system in hematologic malignancies and healthy adults.

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] Many patients with leukemia experience cancer-related fatigue (CRF). However, when patients are admitted for treatment with chemotherapy, clinicians often overlook CRF and interventions that can help to manage it. The purpose of this four-week intervention was to determine whether a nurse-led exercise activity would reduce CRF and increase physical activity compared to current practice. The results suggest that nurse-led exercise programs can immediately decrease CRF and increase activity in admitted patients with leukemia receiving chemotherapy. Including patients in nurse-led exercise activities can support active participation in their own care during and after hospitalization.