Exercise program for children and young adults with cancer
LCI-PED-NOS-EXER-001: Just Move. A Randomized Controlled Trial Investigating Exercise in Pediatric Oncology Patients
This study tests if a structured exercise program can help children and young adults with cancer feel better physically and emotionally while they are undergoing treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 2 Years to 25 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Charlotte, North Carolina) |
| Trial ID | NCT05058508 on ClinicalTrials.gov |
What this trial studies
This study investigates the physical and emotional benefits of a structured exercise regimen for pediatric patients aged 2-25 who are newly diagnosed with blood or solid tumor cancers and undergoing treatment. Participants will be randomly assigned to either the exercise intervention group or a control group receiving standard care. The effectiveness of the exercise program will be measured using the 6-Minute Walk test and other assessments to evaluate physical functioning. The goal is to determine if exercise can help maintain or improve physical capabilities during cancer treatment.
Who should consider this trial
Good fit: Ideal candidates are children and young adults aged 2-25 who have recently been diagnosed with cancer and are about to start chemotherapy.
Not a fit: Patients with known cardiac dysfunction or certain types of tumors, such as primary CNS tumors or osteosarcoma, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the physical and emotional well-being of young cancer patients during their treatment.
How similar studies have performed: Other studies have shown positive outcomes with exercise interventions in pediatric oncology, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ages 2-25 at time of consent 2. Subject has newly diagnosed cancer per Investigator, and is planning to undergo chemotherapy for treatment of malignancy for at least 3 full cycles 3. Ability of subject (and/or parent/guardian) to read and understand the English or Spanish language 4. As determined and documented by the enrolling investigator, ability of the subject to understand and comply with study procedures for the entire length of the study 5. Subject has newly diagnosed cancer per Investigator and is planning to undergo chemotherapy, immunotherapy, or other systemically delivered for treatment of malignancy. Subjects are allowed to be enrolled up to 21 days after initiating cancer treatment. 6. Receiving oncologic care at Levine Children's Cancer and Blood Disorders Clinic. 7. Subject is anticipated to receive at least 3 full cycles of chemotherapy or other systemic cancer treatment. 8. Not participating in another clinical trial that precludes participating in additional nondrug clinical trials. Exclusion Criteria: 1. Known cardiac dysfunction that, in the opinion of the investigator, would be unsafe for the child to participate in the exercise program 2. Any other uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements or would be considered unsafe for the child to participate as determined by the Investigator. 3. Recent (within 4 weeks of enrollment) or planned surgery that will result in prolonged limited mobility not amendable to exercise modifications per investigator discretion 4. Primary CNS Tumor 5. Osteosarcoma
Where this trial is running
Charlotte, North Carolina
- Levine Children's Hospital — Charlotte, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Pope, MD — Wake Forest University Health Sciences
- Study coordinator: Meg Lattanze
- Email: Megan.Lattanze@advocatehealth.org
- Phone: (980) 442-4239
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.