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

LCI-PED-NOS-EXER-001: Just Move. A Randomized Controlled Trial Investigating Exercise in Pediatric Oncology Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Cancer
• Intervention / Treatment: Other: "Just Move" Exercise; Other: Standard of Care Exercise

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meg Lattanze; Phone Number: (980) 442-4239; Email: Megan.Lattanze@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Recruiting
      • Levine Children's Hospital
      • Principal Investigator: Jennifer Pope, MD
      • Contact: Meg Lattanze; Phone Number: 980-442-4239; Email: Megan.Lattanze@advocatehealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXER; "Just Move" exercises	Other: "Just Move" Exercise; Subjects complete "Just Move" Exercises Five Times Per Week
Experimental: SOC EXER; Standard of Care Exercise	Other: Standard of Care Exercise; Subjects exercise/move as tolerated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event Rate	Occurrence of Adverse Events of Special Interest (thromboembolic event, skin ulceration, significant nausea/vomiting, and constipation) will be measured as binary variables.	up to 18 months
Quality of Life measured by the PedsQL Cancer Module	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).	up to 18 months
Adverse Events Related to Exercise Program	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.	up to 18 months
Subject adherence to exercise regimen	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.	up to 18 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Atrium Health Levine Cancer Institute
• Investigators: Principal Investigator: Jennifer Pope, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; Pediatric Oncology
• Additional Relevant MeSH Terms: Behavior; Neoplasms; Motor Activity
• Other Study ID Numbers: IRB00082746; LCI-PED-NOS-EXER-001 (Other Identifier: Atrium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No