Recruiting

Exercise

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05058508

Conditions

Pediatric Cancer

Eligibility Criteria

Sex: All

Age: 2 - 25

Healthy Volunteers: Not accepted

Interventions

"Just Move" Exercise

Standard of Care Exercise

Study Details

Brief summary:

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.

Conditions

Pediatric Cancer

Study ID

NCT05058508

Start date

Mar 11, 2024

Status verified date

Jul, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 25

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: EXER

"Just Move" exercises

experimental: SOC EXER

Standard of Care Exercise

Interventions

"Just Move" Exercise

Subjects complete "Just Move" Exercises Five Times Per Week

Standard of Care Exercise

Subjects exercise/move as tolerated

Primary outcome measure

  • Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment [ Time Frame: 18 month period ]
  • Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment [ Time Frame: 18 month period ]

Central Contacts and Locations

Locations

Levine Children's Hospital

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Principal Investigator:

Jennifer Pope, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Exercise
  • Pediatric Oncology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-22.