LCI-PED-NOS-EXER-001: Exercise in Pediatric Oncology Patients
ConditionPediatric Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-25
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
"Just Move" Exercise
Other interventionSubjects complete "Just Move" Exercises Five Times Per Week
Standard of Care Exercise
Other interventionSubjects exercise/move as tolerated
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: EXERExperimental treatment 1 intervention
Group B: SOC EXERExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
18 month period2
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).
Time frame
18 month periodSecondary outcomes
1
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.
Time frame
up to 18 months2
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).
Time frame
up to 18 months3
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.
Time frame
up to 18 months4
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.
Time frame
up to 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
Atrium Health Levine Cancer Institute
Collaborator
Source ClinicalTrials.gov