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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pediatric Cancer

Intervention / Treatment
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* Other: Just Move Exercise
* Other: Standard of Care Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 2-25 at time of consent Subject has newly diagnosed cancer per Investigator, and is planning to undergo chemotherapy for treatment of malignancy Ability of subject (and/or parent/guardian) to read and understand the English or Spanish language Subject is anticipated to receive at least 3 months of chemotherapy or other cancer treatment. 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 Exclusion Criteria: Known cardiac dysfunction that, in the opinion of the investigator, would be unsafe for the child to participate in the exercise program 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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXER<br>Just Move exercises | Other: Just Move Exercise<br>* Subjects complete Just Move Exercises Five Times Per Week<br>|
| Experimental: SOC EXER<br>Standard of Care Exercise | Other: Standard of Care Exercise<br>* Subjects exercise/move as tolerated<br>|

What is the study measuring?
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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 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 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 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). | 18 month period |