Exercise Training for Blood Cancers Survivorship

(S-POP Trial)

Overseen By Amy Bush, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Recent cardiac event, Unstable angina, Uncontrolled dysthymias, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how 12 weeks of exercise, including high-intensity interval training (HIIT) and resistance training, can improve health in individuals who have undergone a stem cell transplant for blood cancer. It also examines the exercise's impact on caregivers, focusing on their health and challenges. Individuals who have had a stem cell transplant and their caregivers may be suitable participants if they are approximately three months post-transplant and can safely exercise. As an unphased trial, this study provides a unique opportunity to contribute to understanding the benefits of exercise post-transplant for both patients and caregivers.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that exercise training is safe for patients and caregivers undergoing hematopoietic stem cell transplant?

Research shows that exercise is generally safe for cancer survivors. Studies have found that physical activity plays a crucial role in recovery after a transplant. Exercise not only reduces cancer-related fatigue but also enhances overall well-being. Reviews of research confirm the safety of exercise programs for adults with cancer, with no major issues reported. In fact, exercise often improves health and quality of life for cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise training regimen for blood cancer survivorship because it offers a non-pharmaceutical approach to improve overall well-being post-transplant. Unlike traditional treatments that focus solely on medical interventions, this exercise program aims to enhance physical function, cognitive health, and quality of life through structured physical activity. Additionally, it uniquely involves both patients and their caregivers, emphasizing a holistic approach to recovery and support. By incorporating assessments of social support and financial status, researchers hope to gain a comprehensive understanding of survivorship, potentially transforming post-transplant care.

What evidence suggests that exercise training is effective for blood cancer survivorship?

Research has shown that exercise can greatly aid people recovering from blood cancers. It strengthens the body, reduces fatigue, and enhances overall quality of life. Studies have found that exercise can also lower the risk of cancer recurrence and might even surpass some medicines in effectiveness for prevention. In this trial, participants, including both post-allogeneic hematopoietic stem cell transplant patients and their caregivers, will complete 12 weeks of exercise training. For those who have undergone a stem cell transplant, exercise has been linked to better physical health and shorter hospital stays. Overall, exercise is generally safe and can improve mental health and reduce depression in cancer survivors. ^{1 6 7 8 9}

Who Is on the Research Team?

Chenyu Lin, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 who have had a hematopoietic stem cell transplant (HCT) within the last 60 to 120 days, as well as their caregivers. It's designed to help improve various aspects of health post-transplant.

Inclusion Criteria

I am taking care of someone who has had a stem cell transplant.

I had a bone marrow transplant from a donor within the last 60 to 120 days.

I'm sorry, it seems like you did not complete the criteria. Could you please provide me with more information?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 12 weeks of high-intensity interval training (HIIT) and resistance training to improve physical and cognitive function, mental health, and quality of life

12 weeks

Regular visits for exercise sessions and assessments

Follow-up

Participants are monitored for changes in physical function, mental health, and quality of life post-intervention

1 year

Assessments at baseline, post-intervention, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Exercise training

Trial Overview

The study is testing a program that includes high-intensity interval training (HIIT) and resistance exercises over a period of 12 weeks. The goal is to see how this exercise regimen affects physical function, cognitive abilities, mental health, and overall quality of life after HCT.

How Is the Trial Designed?

Group I: Patient Experimental Treatment 1 Intervention

These are patients who are 90 (±30) days post-allogeneic hematopoietic stem cell transplant. Patients will complete 12 weeks of exercise training. Patients will also complete assessments to evaluate physical function, cognitive function, mental health, social support, nutrition and diet, symptoms, quality of life, and financial status. They will use devices to capture activity data and vital signs. They will collect bio-specimens to assess microbiota and biomarkers.

Group II: Caregiver Experimental Treatment 1 Intervention

These are the assigned caregivers for the transplant patients. Caregivers will complete 12 weeks of exercise training. Caregivers will also complete assessments to evaluate physical function, caregiver support, and physical activity and exercise. They will collect bio-specimens to assess microbiota.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

In a review of 24 adult studies, strong evidence indicates that exercise interventions significantly improve body composition in hematological cancer survivors, while there is promising but weaker evidence for benefits in cardiorespiratory fitness, fatigue, muscle strength, physical functioning, and quality of life.

For pediatric survivors, 13 studies showed strong evidence that exercise, especially in hospital settings, enhances muscle strength and cardiorespiratory fitness, with no exercise-related risks identified for either adults or children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in adult and pediatric hematological cancer survivors: an intervention review. Wolin, KY., Ruiz, JR., Tuchman, H., et al.[2013]

Exercise training significantly improves endothelial function, as measured by flow-mediated dilation, in cancer patients compared to usual care, based on a systematic review of 10 studies involving 504 participants.

However, exercise did not show a significant effect on arterial stiffness, indicating that while exercise can enhance certain aspects of vascular health during cancer treatment, it may not address all vascular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of exercise training for improving vascular dysfunction in people with cancer: a systematic review with meta-analyses. Vear, NK., Moon, Y., Mielke, GI., et al.[2023]

Exercise is an effective therapeutic intervention for cancer patients, helping to reduce side effects from treatments and significantly improving their quality of life during and after treatment.

Engaging in exercise before, during, and after cancer treatments leads to numerous beneficial outcomes, making it a crucial part of care for both patients undergoing treatment and survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Recommendations for Cancer-Related Fatigue, Cognitive Impairment, Sleep problems, Depression, Pain, Anxiety, and Physical Dysfunction: A Review. Mustian, KM., Sprod, LK., Janelsins, M., et al.[2021]

Exercise training is a safe and well-tolerated adjunct therapy for cancer patients, showing potential to reduce treatment-related side effects during and after adjuvant therapy.

Current evidence suggests that incorporating exercise into the care plan for cancer survivors may enhance their overall management, although further research is needed to fully understand its benefits across different stages of cancer survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise therapy in the management of solid tumors. Jones, LW., Peppercom, J., Scott, JM., et al.[2021]

A 12-week oncology rehabilitation program combining aerobic and resistance training significantly improved muscle strength and physical function in both middle-aged (45 to 64 years) and older (≥ 65 years) cancer survivors.

While both age groups benefited from the exercise program, older participants showed less improvement in specific measures like leg strength and the 5 time sit to stand test, indicating that age may limit the extent of physical recovery after cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an exercise-based oncology rehabilitation program and age on strength and physical function in cancer survivors. Dittus, K., Toth, M., Priest, J., et al.[2021]

Exercise therapy significantly improves cardiorespiratory fitness in cancer patients and helps reduce the cardiotoxic effects of cancer treatments, making it a crucial part of cardiac rehabilitation programs.

Starting exercise early after a cancer diagnosis and continuing throughout survivorship is generally safe and beneficial for heart health in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training for Cancer Survivors. Tong, CKW., Lau, B., Davis, MK.[2021]

Regular physical exercise is associated with a reduced risk of developing colorectal and breast cancer, and may also lower the risk for prostate, endometrial, and lung cancers, based on a review of recent literature.

Exercise is beneficial for cancer survivors, aiding in recovery from treatment and potentially extending survival, although specific guidelines on the optimal amount, type, and intensity of exercise are still being developed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in cancer. Rajarajeswaran, P., Vishnupriya, R.[2021]

A 6-week supervised exercise program for 61 cancer patients improved their physical activity levels compared to baseline, but there was a significant drop in activity levels during the follow-up period, indicating the need for ongoing support.

The study found that patients who maintained higher levels of physical activity three months after the program were those who had been more active before their illness and experienced less psychological distress, suggesting that pre-illness activity and mental health are important for sustaining exercise adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of supervised exercise intervention on short-term postprogram leisure time physical activity level in cancer patients undergoing chemotherapy: 1- and 3-month follow-up on the body & cancer project. Midtgaard, J., Tveterås, A., Rørth, M., et al.[2019]

Physical activity and targeted exercise therapy can significantly improve outcomes for cancer patients, helping to manage side effects like fatigue and depression, especially when introduced right after diagnosis.

Moderate endurance training combined with individualized strength training is particularly effective and can be recommended for all cancer patients, regardless of cancer type, while ensuring contraindications are considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical activity and exercise therapy in oncology]. Zoth, N., Böhlke, L., Theurich, S., et al.[2023]

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 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]

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]

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