LCI-PED-NOS-EXER-001: Exercise in Pediatric Oncology Patients

Wake Forest University (WFU)

Status: Enrolling

Conditions: Pediatric Cancer

Treatments: Other: "Just Move" Exercise; Other: Standard of Care Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05058508

LCI-PED-NOS-EXER-001

IRB00082746

Details and patient eligibility

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.

Full description

This is a randomized, controlled trial to investigate if a structured exercise regimen 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 and BOT-2 Brief or PDMS-2.

Enrollment: 60 estimated patients

Sex: All

Ages: 2 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

EXER

Experimental group

Description:

"Just Move" exercises

Treatment:

Other: "Just Move" Exercise

SOC EXER

Experimental group

Description:

Standard of Care Exercise

Treatment:

Other: Standard of Care Exercise