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

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05058508
• Other study ID #: IRB00082746
• Secondary ID: LCI-PED-NOS-EXER
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: October 1, 2025

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: Anna Zykova
• Phone: 980-442-2323
• Email: anna.zykova[@]atriumhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 25 Years

Eligibility

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

3. Ability of subject (and/or parent/guardian) to read and understand the English or Spanish language

4. Subject is anticipated to receive at least 3 months of chemotherapy or other cancer treatment.

5. 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:

1. Known cardiac dysfunction that, in the opinion of the investigator, would be unsafe for the child to participate in the exercise program

2. Recent (within 4 weeks of enrollment) or planned surgery that will result in prolonged limited mobility not amendable to exercise modifications per investigator discretion

3. Primary CNS Tumor

4. Osteosarcoma

Related Conditions & MeSH terms

• Neoplasms
• Pediatric Cancer

Intervention

Other:
• "Just Move" Exercise
Subjects complete "Just Move" Exercises Five Times Per Week
• Standard of Care Exercise
Subjects exercise/move as tolerated

Locations

Country	Name	City	State
United States	Levine Children's Hospital	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Atrium Health Levine Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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