Exercise for Blood Cancer

(Allo-X Trial)

Overseen By Forrest L Baker, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Arizona

Must not be taking: Antidepressants, Immune modulators, others

Disqualifiers: Tobacco use, High BMI, Cardiovascular disease, Autoimmune disease, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether exercise can enhance immune cells for blood cancer treatment. The goal is to improve a therapy where cells from healthy donors are given to cancer patients to prevent relapse after a stem cell transplant. Researchers are testing exercise, exercise combined with a stress-reducing drug, and a drug that mimics exercise effects to determine which best boosts immune cells. Healthy individuals with no more than one risk factor for heart disease and who do not smoke are eligible to join. The study aims to make treatments safer and more effective by reducing side effects like graft-versus-host disease (GvHD). As an Early Phase 1 trial, this research focuses on understanding how these interventions work in people, offering participants a chance to contribute to groundbreaking treatment advancements.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications that affect the immune system, ibuprofen/aspirin, antidepressants, or medications that alter blood pressure or cardiovascular function, as well as any prescription medications or beta-blockers.

What prior data suggests that exercise is safe for improving immune cell therapies in blood cancer treatment?

Earlier research has found exercise to be generally safe and capable of lessening the side effects of cancer treatment. It also appears to improve patients' overall quality of life, making it a promising treatment component with few safety concerns.

Isoproterenol, a drug that mimics the effects of exercise, has safely increased certain immune cells, similar to exercise. However, medical supervision is usually required because it can affect heart rate and blood pressure.

In this study, both exercise and isoproterenol are expected to be well-tolerated, especially since the trial is in Early Phase 1. This phase primarily focuses on ensuring the treatments are safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the "Exercise for Blood Cancer" trial because it explores how exercise might boost the immune system in ways similar to traditional treatments but without the side effects. Unlike standard blood cancer treatments, which often involve chemotherapy or targeted drugs, exercise uses the body's natural systems to potentially fight cancer. The trial is also examining whether activating certain receptors in the body through medication can mimic the benefits of exercise, offering a new perspective on how we could enhance cancer care. This approach is unique because it combines physical activity with pharmacological strategies to explore new ways of supporting the immune response in blood cancer patients.

What evidence suggests that exercise could be an effective treatment for blood cancer?

This trial will compare the effects of exercise and isoproterenol infusion on the immune system in healthy participants. Research has shown that exercise, which participants in the Exercise Cohort will undergo, can strengthen the immune system and improve outcomes for people with blood cancers. Exercise enhances immune function and can make the environment around tumors less favorable for cancer growth. Studies also suggest that physical activity may reduce the risk of cancer recurrence and enhance overall quality of life.

In the Isoproterenol Infusion Cohort, participants will receive isoproterenol infusion. Research has found that isoproterenol can improve the composition and function of immune cells, similar to exercise. It increases certain immune cells, such as lymphocytes and NK-cells, which are white blood cells that help destroy cancer cells. This suggests that isoproterenol might aid in developing more effective immune cell treatments for blood cancer patients. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy individuals who can donate immune cells to help improve blood cancer treatments. It's not specified, but typically participants should be adults, in good health, and able to perform exercise or take medications as required by the study.

Inclusion Criteria

Participants must be classified as 'low-risk' for graded exercise/stress testing according to ACSM-AHA criteria

I am between 21 and 55 years old.

I can safely use certain heart and lung medications as per FDA guidelines.

Exclusion Criteria

I have heart issues or can't take certain heart medications.

I am currently using tobacco or quit less than 6 months ago.

Participants with central or peripheral nervous disorders, a history of stroke, or major affective disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Exercise Cohort

Participants undergo a graded exercise test and two exercise sessions to collect blood samples for immune cell analysis.

3-4 weeks

3 visits (in-person)

Exercise + Beta Blocker Cohort

Participants complete five exercise trials with drug or placebo administration to study the effects on immune cells.

6-10 weeks

6 visits (in-person)

Isoproterenol Cohort

Participants receive isoproterenol infusion to mimic exercise effects on immune cells.

2-3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after interventions.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

Trial Overview The trial tests if exercise or certain drugs (beta blockers and isoproterenol) can produce healthier immune cells from donors for cell therapies used in treating blood cancers like lymphoma and leukemia. The study has three groups: one exercising, one taking beta blockers with exercise, and one receiving a drug mimicking adrenaline effects.

How Is the Trial Designed?

Group I: Isoproterenol Infusion Cohort Experimental Treatment 1 Intervention

To determine if pharmacological activation of beta-adrenergic receptors evokes an immune respponse akin to exercise, healthy participants will receive an intravenous infusion of isoproterenol (50ng/kg/min)

Group II: Exercise Cohort Experimental Treatment 1 Intervention

After an initial maximal graded exercise test to determine maximal oxygen uptake and peak cycling power, healthy participants will undergo a 20-minute graded exercise test at intensities corresponding to 50, 60, 70 and 80% VO2max (5-minutes per stage)

Group III: Exercise + Beta Blocker Cohort Placebo Group 5 Interventions

Healthy participants will complete a 20-minute graded exercise test at intensities ranging from 50-80-% of the maximal oxygen uptake under the following conditions: (1) Placebo; (2) 10mg bisoprolol ingestion; (3) 80ng nadolol ingestion; (4) 50ng carvedilol ingestion; (5) 10mg bisoprolol + 100mcg roflumilast ingestion. All drugs and placebo will be ingested 2-3h prior to exercise. Trial conditions will be double-blind and cross over with each participant serving as their own cntrol

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

A 12-week exercise rehabilitation program significantly improved cancer-related fatigue, cardiovascular fitness, quality of life, muscle strength, and body composition in hematological cancer patients, with no adverse reactions reported.

Patients who initially received usual care showed similar significant improvements after participating in a delayed exercise program, indicating the lasting benefits of exercise rehabilitation for cancer recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial comparing the effects of a 12-week supervised exercise versus usual care on outcomes in haematological cancer patients. Furzer, BJ., Ackland, TR., Wallman, KE., et al.[2019]

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 systematic review of 8 studies found that exercise interventions significantly improve cardiorespiratory fitness and lower extremity muscle strength in patients with hematologic malignancies undergoing stem cell transplantation, with effect sizes of 0.53 and 0.56, respectively.

Exercise also helps reduce fatigue and positively impacts overall quality of life, although all studies had some risk of bias, indicating a need for further high-quality research to confirm these benefits and optimize exercise interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise in patients treated with stem cell transplantation for a hematologic malignancy: a systematic review and meta-analysis. Persoon, S., Kersten, MJ., van der Weiden, K., et al.[2022]

Exercise therapy significantly improves cardiorespiratory fitness (CRF) in patients with adult-onset cancer, with an average increase of 2.80 mL O2 × kg-1 × min-1 compared to no change in control groups, based on a review of 48 randomized controlled trials involving 3,632 patients.

The study found that exercise therapy is safe, with only 44 adverse events reported across 30 trials, and high adherence rates (88%) suggest that patients are likely to stick with the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Exercise Therapy on Cardiorespiratory Fitness in Patients With Cancer: A Systematic Review and Meta-Analysis. Scott, JM., Zabor, EC., Schwitzer, E., et al.[2022]

Exercise interventions significantly improve lower muscle strength, fatigue, and quality of life in patients undergoing hematopoietic stem cell transplantation, based on a meta-analysis of randomized controlled trials.

Starting exercise before transplantation is optimal for enhancing muscle strength and quality of life, with no increase in adverse events such as graft vs host disease or mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for physical fitness, fatigue and quality of life of patients undergoing hematopoietic stem cell transplantation: a meta-analysis of randomized controlled trials. Liang, Y., Zhou, M., Wang, F., et al.[2022]

A systematic review of 15 studies found that exercise interventions significantly improved physical fitness in adults with hematological malignancies, as measured by the 6-minute walk test and peak oxygen consumption.

While exercise did not show significant effects on grip strength, fatigue, or overall quality of life when comparing groups, within-group analysis indicated that combination exercise improved quality of life for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise interventions for physical fitness, fatigue, and quality of life in adult hematologic malignancy patients without receiving hematopoietic stem cell transplantation: a systematic review and meta-analysis. Xu, W., Yang, L., Wang, Y., et al.[2022]

Patients with hematologic malignancies often experience significant physical and cognitive challenges, highlighting the need for early and comprehensive rehabilitation services, including exercise interventions.

Current research suggests that exercise is generally safe and can lead to functional improvements for patients with hematologic cancers, but more studies are needed to establish effective guidelines, especially for those undergoing stem cell transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation and exercise considerations in hematologic malignancies. Paul, KL.[2016]

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]

Citations

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Impact of exercise on the immune system and outcomes in ... Thus, exercise in patients with hematologic cancer could significantly improve immune function and tumor microenvironment. We performed a ...

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What Are the Benefits of Exercise for Cancer Patients? | Blog Studies have also shown that physical activity can help lower the recurrence of cancers, improve overall quality of life, and even increase survival.

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Effects of Exercise on Cancer Treatment Efficacy: A Systematic ... Exercise significantly enhanced the efficacy of chemotherapy and tamoxifen in seven of eight rodent models in either an additive, sensitizing, or synergistic ...

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Physical Activity and Cancer Care—A Review - PMC The findings from these studies show that physical activity decreases the severity of side effects of cancer treatment, reduces fatigue, improves quality of ...

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Exercise and cancer outcomes: What do we know and ... Encouraging data showing exercise inversely correlated with breast cancer mortality. • Emerging data for colorectal and prostate cancer. • Initial data showing ...

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Physical Activity and Cancer Fact Sheet - NCI A pooled analysis of over 1 million individuals found that leisure-time physical activity was linked to a 13% reduced risk of bladder cancer (6) ...

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The Physical Activity and Cancer Control (PACC) framework Leisure-time physical activity within the recommended level (7.5–15 MET hours/week) was associated with 6–29% risk reduction among several ...