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

Not Applicable

Recruiting

• Conditions: Pediatric Cancer

• Registration Number: NCT05058508
• Lead Sponsor: Wake Forest University Health Sciences

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-09-27
• Study Start: 2024-03-11
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-16
• Primary Completion: 2027-11
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 5 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 cycles90 days 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment	18 month period	Investigate if 20 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).

Secondary Outcome Measures

Name	Time	Method
Adverse Events Related to Exercise Program	up to 18 months	To summarize adverse event rates deemed to be related to the protocol directed exercise program. Adverse events of special interest (Grade 2 or greater Bone fracture, Fall, and Muscle aches/Myalgia) will be captured for each subject and time point randomized to the intervention arm.
Adverse Event Rate	up to 18 months	Occurrence of Adverse Events of Special Interest (thromboembolic event, skin ulceration, significant nausea/vomiting, and constipation) will be measured as binary variables.
Quality of Life measured by the PedsQL Cancer Module	up to 18 months	Investigate if a structured exercise regimen relative to the control arm will result in Increasing and /or maintaining quality of life as measured by the PedsQL Cancer Module. Peds QL scores will be calculated as a composite quantitative analogue variable ranging from zero (best score) to 100 (worst score).
Subject adherence to exercise regimen	up to 18 months	Subject adherence to exercise regimen will be determined by patient-reported tracker listing activity performed and duration of time of activity. Data collected will be normalized quantitatively based on intended activity.

Trial Locations

Locations (1)

Levine Children's Hospital; 🇺🇸 Charlotte, North Carolina, United States