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

NCT05058508 | Recruiting DMC

• 2 other identifiers: IRB00082746LCI-PED-NOS-EXER-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Exercise; Pediatric Oncology

Outcome Measures

Primary Outcomes (2)

• Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment

  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

  18 month period

• Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment

  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).

  18 month period

Secondary Outcomes (4)

• Adverse Event Rate

  up to 18 months

• Quality of Life measured by the PedsQL Cancer Module

  up to 18 months

• Subject adherence to exercise regimen

  up to 18 months

• Adverse Events Related to Exercise Program

  up to 18 months

Study Arms (2)

EXER

EXPERIMENTAL

"Just Move" exercises

Other: "Just Move" Exercise

SOC EXER

EXPERIMENTAL

Standard of Care Exercise

Other: Standard of Care Exercise

Interventions

Standard of Care Exercise OTHER

Subjects exercise/move as tolerated

SOC EXER

"Just Move" Exercise OTHER

Subjects complete "Just Move" Exercises Five Times Per Week

EXER

Eligibility Criteria

• Age: 2 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Atrium Health Levine Cancer Institute: collaborator

Study Sites (1)

Levine Children's Hospital

Charlotte, North Carolina, 28203, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jennifer Pope, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meg Lattanze

CONTACT

(980) 442-4239; Megan.Lattanze@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 27, 2021
• Study Start: March 11, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)