Exercise for Pediatric Cancer

Overseen By Alicia Patrick

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Jamie Mochel

Disqualifiers: Cardiac dysfunction, Recent surgery, CNS tumor, Osteosarcoma

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

Compensation: Varies

Number of Visits: 5

Duration: 18 months

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see if there are physical and emotional benefits to participating in a structured exercise regimen for those who are ages 2-25, are newly diagnosed with a blood or solid tumor cancer, and are currently undergoing or will begin cancer treatment.

Do I have to stop taking my current medications for 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 team or your doctor.

What data supports the effectiveness of the treatment Just Move Exercise for pediatric cancer?

Research shows that exercise interventions for children with cancer are safe and can improve health without causing harm. Studies highlight good adherence to exercise programs and positive health trends, suggesting that regular physical activity can help manage the side effects of cancer treatment in children. ^{1 2 3 4 5}

Is exercise safe for children with cancer?

Exercise programs for children with cancer have been shown to be safe, with no reported harmful effects. Studies recommend supervised and adaptable exercise activities to support health without causing harm. ^{2 3 4 6 7}

How is exercise therapy different from other treatments for pediatric cancer?

Exercise therapy for pediatric cancer is unique because it focuses on promoting physical activity to counteract the negative side effects of cancer treatment, such as reduced motor development and increased psychological stress. Unlike traditional medical treatments, it involves individualized, supervised exercise programs that adapt to the child's changing abilities, aiming to improve overall health and well-being during and after cancer treatment. ^{2 3 4 5 8}

Research Team

Jennifer Pope, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for children and young adults aged 2-25 who have been newly diagnosed with blood or solid tumor cancers, excluding osteosarcoma and primary CNS tumors. Participants must be starting or undergoing cancer treatment expected to last at least 3 months, able to understand English or Spanish, and capable of following the study's procedures.

Inclusion Criteria

I am between 2 and 25 years old.

I (or my parent/guardian) can read and understand English or Spanish.

I have been recently diagnosed with cancer and plan to start chemotherapy.

Exclusion Criteria

Known cardiac dysfunction that, in the opinion of the investigator, would be unsafe for the child to participate in the exercise program

I have had or will have surgery soon that limits my movement significantly.

I have been diagnosed with osteosarcoma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a structured exercise regimen while undergoing chemotherapy and childhood cancer treatment

18 months

Regular exercise sessions, 5 days per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Just Move Exercise
• Standard of Care Exercise

Trial Overview The trial is testing two exercise programs: a standard care routine versus a 'Just Move' regimen. It aims to determine if structured physical activity can provide physical and emotional benefits during cancer treatment for pediatric patients.

Participant Groups

Group I: SOC EXER Experimental Treatment 1 Intervention

Standard of Care Exercise

Group II: EXER Experimental Treatment 1 Intervention

"Just Move" exercises

Who Is Running the Clinical Trial?

Jamie Mochel

Lead Sponsor

Trials

1

Recruited

60+

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Atrium Health Levine Cancer Institute

Collaborator

Trials

30

Recruited

4,700+

Findings from Research

Physical therapy (PT) is feasible for children undergoing cancer treatment, as indicated by a review of 12 studies, but the current evidence is insufficient to guide clinical practice.

Future research should focus on specific cancer types and related impairments to better understand the benefits of PT, highlighting the need for collaborative multi-centre trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review of Physical Therapy Interventions for Childhood Cancers. Ospina, PA., McNeely, ML.[2023]

An in-hospital and home exercise program for children with newly diagnosed acute lymphoblastic leukemia (ALL) was found to be feasible, with 98% of evaluation sessions completed among the nine participants aged 2-14 years.

The program led to improvements in gross motor function and health-related quality of life, although there was a slight decrease in quality of life during one treatment phase, indicating the need for further studies to assess long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and parent satisfaction of a physical therapy intervention program for children with acute lymphoblastic leukemia in the first 6 months of medical treatment. Gohar, SF., Comito, M., Price, J., et al.[2011]

Exercise interventions for pediatric cancer patients during inpatient treatment show good adherence and positive trends in health status, based on a review of 10 studies involving 204 patients.

No adverse events were reported, suggesting that physical activity programming can be safely integrated into the care of pediatric oncology inpatients to help mitigate the negative effects of inactivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise interventions for patients with pediatric cancer during inpatient acute care: A systematic review of literature. Rustler, V., Hagerty, M., Daeggelmann, J., et al.[2022]

The guideline emphasizes the importance of implementing standardized exercise interventions for pediatric cancer patients to combat physical inactivity, which can hinder motor development and worsen the side effects of therapy.

It includes 11 recommendations that cover the design of exercise programs, safety issues, and strategies to encourage participation, aiming to improve the overall health and well-being of children undergoing cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary Network ActiveOncoKids guidelines for providing movement and exercise in pediatric oncology: Consensus-based recommendations. Götte, M., Gauß, G., Dirksen, U., et al.[2022]

Physical activity (PA) is safe and beneficial for children and adolescents with cancer, but there are still significant gaps in knowledge and practice regarding its implementation.

The article outlines research and innovation needs identified by international experts, which aim to enhance understanding and practices in pediatric exercise oncology, ultimately helping more young cancer patients benefit from increased physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing the Field of Pediatric Exercise Oncology: Research and Innovation Needs. Wurz, A., McLaughlin, E., Chamorro Viña, C., et al.[2021]

A 6-month group-based exercise program for childhood cancer outpatients significantly improved motor performance, activity levels, and emotional well-being compared to those receiving usual care and healthy peers.

This study highlights the potential of structured exercise interventions to enhance physical and emotional outcomes in pediatric oncology patients after their medical treatment ends.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 6-Month, Group-Based, Therapeutic Exercise Program for Childhood Cancer Outpatients on Motor Performance, Level of Activity, and Quality of Life. Beulertz, J., Prokop, A., Rustler, V., et al.[2022]

Exercise and motor interventions significantly improve various physical outcomes in children with acute lymphoblastic leukemia (ALL) during and after chemotherapy, including fatigue, strength, and aerobic capacity, based on a systematic review of 19 studies involving 508 participants.

Despite the positive findings, the evidence is considered low quality, indicating a need for further research to confirm the efficacy of these interventions for enhancing motor function and physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of exercise and motor interventions on physical activity and motor outcomes during and after medical intervention for children and adolescents with acute lymphoblastic leukemia: A systematic review. Coombs, A., Schilperoort, H., Sargent, B.[2021]

Only 19% of the 48 hospitals surveyed in Germany offer exercise therapy for childhood cancer patients during treatment or aftercare, indicating a significant gap in access to these beneficial interventions.

While the quality of exercise therapy programs in the hospitals that do offer them appears adequate, funding primarily relies on donations and third-party sources, highlighting the need for better financial support and integration into standard healthcare coverage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Quality Characteristics and Prevalence of Exercise Therapy During Childhood Cancer Treatment in Germany]. Söntgerath, R., Freier, S., Wulftange, M., et al.[2018]

References

1. Canada pubmed.ncbi.nlm.nih.gov

A Scoping Review of Physical Therapy Interventions for Childhood Cancers. [2023]

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

Feasibility and parent satisfaction of a physical therapy intervention program for children with acute lymphoblastic leukemia in the first 6 months of medical treatment. [2011]

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

Exercise interventions for patients with pediatric cancer during inpatient acute care: A systematic review of literature. [2022]

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

Multidisciplinary Network ActiveOncoKids guidelines for providing movement and exercise in pediatric oncology: Consensus-based recommendations. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Advancing the Field of Pediatric Exercise Oncology: Research and Innovation Needs. [2021]

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

Effects of a 6-Month, Group-Based, Therapeutic Exercise Program for Childhood Cancer Outpatients on Motor Performance, Level of Activity, and Quality of Life. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of exercise and motor interventions on physical activity and motor outcomes during and after medical intervention for children and adolescents with acute lymphoblastic leukemia: A systematic review. [2021]

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

[Quality Characteristics and Prevalence of Exercise Therapy During Childhood Cancer Treatment in Germany]. [2018]