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

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05058508
Collaborator
(none)
60
1
2
24
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: "Just Move" Exercise
  • Other: Standard of Care Exercise
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
LCI-PED-NOS-EXER-001: Just Move. A Randomized Controlled Trial Investigating Exercise in Pediatric Oncology Patients
Actual Study Start Date :
Mar 2, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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 6-Minute Walk test

  2. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Levine Children's Hospital Charlotte North Carolina United States 28203

Sponsors and Collaborators

  • Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Jamie Mochel, MSN, CPNP-AC, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT05058508
Other Study ID Numbers:
  • IRB00082746
  • LCI-PED-NOS-EXER-001
First Posted:
Sep 27, 2021
Last Update Posted:
Apr 21, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 21, 2022