NCT05058508 · Wake Forest University Health Sciences
LCI-PED-NOS-EXER-001: Exercise in Pediatric Oncology Patients
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
"Just Move" Exercise
Subjects complete "Just Move" Exercises Five Times Per Week
OTHER
Standard of Care Exercise
Subjects exercise/move as tolerated
Primary outcome measures
Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment
Time frame: 18 month period
Investigate if 30 minutes of exercise, five days per week, will have benefit relative to the control arm by increasing and/or maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment as measured by 6-Minute Walk test
Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment
Time frame: 18 month period
Investigate if 30 minutes of exercise, five days per week, will have benefit relative to the control arm by increasing and/or maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment as measured by BOT-2 Brief (in subjects ≥ 4 years of age) or PDMS-2 (in subjects \< 4 years of age).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Ages 2-25 at time of consent
- Subject has newly diagnosed cancer per Investigator, and is planning to undergo chemotherapy for treatment of malignancy for at least 3 full cycles
- Ability of subject (and/or parent/guardian) to read and understand the English or Spanish language
- 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
- 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.
- Receiving oncologic care at Levine Children's Cancer and Blood Disorders Clinic.
- Subject is anticipated to receive at least 3 full cycles of chemotherapy or other systemic cancer treatment.
- Not participating in another clinical trial that precludes participating in additional nondrug clinical trials.
Exclusion criteria
- Known cardiac dysfunction that, in the opinion of the investigator, would be unsafe for the child to participate in the exercise program
- 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.
- Recent (within 4 weeks of enrollment) or planned surgery that will result in prolonged limited mobility not amendable to exercise modifications per investigator discretion
- Primary CNS Tumor
- Osteosarcoma
Where
- Charlotte, North Carolina
Collaborators
Atrium Health Levine Cancer Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 22, 2026 · Source of record for eligibility and locations