Exercise for Pediatric Cancer

Overseen By Meg Lattanze

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a structured exercise program can improve physical and emotional well-being in young people recently diagnosed with cancer. It compares two exercise approaches: a specific "Just Move Exercise" regimen and standard exercise care. The trial is open to individuals aged 2 to 25 who have been newly diagnosed with either a blood or solid tumor cancer and are scheduled for cancer treatment. Participants must receive care at Levine Children's Cancer and Blood Disorders Clinic and be able to participate in English or Spanish. As an unphased trial, this study offers a unique opportunity to contribute to understanding how exercise can support the well-being of young cancer patients.

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 prior data suggests that these exercise regimens are safe for pediatric cancer patients?

Research shows that exercise is generally safe and well-tolerated for children with cancer. Studies have found that exercise can enhance both the physical and emotional health of these patients. For example, one review found that physical activity improves physical, mental, and daily functioning in children with cancer.

Moreover, increased activity is linked to a lower risk of death and heart problems in childhood cancer survivors. This suggests that exercise programs like "Just Move" are likely safe and beneficial for children with cancer. Although specific side effects weren't highlighted, the overall evidence supports the safety of structured exercise for this group. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Just Move" exercise program for pediatric cancer patients because it emphasizes a structured and possibly more engaging approach to physical activity than the standard exercise recommendations. While standard care typically involves general physical activity guidelines, "Just Move" may offer tailored exercises that are specifically designed to improve strength and well-being in young cancer patients. This trial could reveal whether this targeted exercise protocol can provide better outcomes in terms of physical health and quality of life during treatment.

What evidence suggests that this trial's exercise regimens could be effective for pediatric cancer patients?

Research has shown that physical activity can benefit children and teens undergoing cancer treatment. In this trial, participants will join one of two exercise programs. The "Just Move" routine, one study arm, has been found to reduce cancer-related fatigue and enhance the quality of life for young cancer survivors. The other arm involves Standard of Care Exercise. Regular exercise during treatment may also improve health both now and in the future. Exercise benefits both the body and mind of young cancer patients. Overall, structured exercise programs are linked to better recovery and treatment success. ^{1 6 7 8 9}

Who Is on the Research Team?

Jennifer Pope, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7778568/

Physical activity for pediatric cancer survivors - PubMed Central The study found that the program was effective in reducing cancer-related fatigue among Chinese pediatric cancer survivors [33]. Quality of life.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1413355523000989

Promoting positive physical activity behaviours in children ... Maximising a child/adolescent's physical activity participation during acute cancer treatment has potential to improve immediate and long-term health outcomes.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06839794

Effect of Cognitively Challenging Physical Activity on ... This broad spectrum of effects of physical activity leads to improved and faster rehabilitation, is directly linked to the success of treatment and has led to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10048410/

Effects of Exercise and Physical Activity Levels on Childhood ... Exercise interventions had a positive effect on many physiological and psychological health outcomes in pediatric cancer patients and survivors.

5. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2020.00243/full

Benefits of Exercise Training for Children and Adolescents ... The present study provides evidence for a positive effect of combined training in CCPs during intensive cancer treatment.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0305737218301543

Exercise training in childhood cancer: A systematic review ... Indeed, when compared with pre-diagnosis levels, children and adolescents with cancer experience a 74% and 91% reduction in their habitual physical activity ...

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06813950

Impact of a Physical Activity Program on the Health-Related ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12025492/

Supervised Physical Activity Interventions in Children and ... This systematic review aims to (1) assess the impact of physical activity interventions on physical, psychological, and functional outcomes in ...

9. cinj.org cinj.org/childhood-cancer-survivors-and-physical-activity

Childhood Cancer Survivors and Physical Activity Research suggests that increased physical activity is associated with lower risk of death and cardiovascular events among childhood cancer ...