LCI-PED-NOS-EXER-001: Exercise in Pediatric Oncology Patients
- Conditions
- Pediatric Cancer
- Interventions
- Other: "Just Move" ExerciseOther: Standard of Care Exercise
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EXER "Just Move" Exercise "Just Move" exercises SOC EXER Standard of Care Exercise Standard of Care Exercise
- 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