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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment [Time frame: 18 month period]
• Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment [Time frame: 18 month period]

Secondary outcome measures (4)

• Adverse Event Rate [Time frame: up to 18 months]
• Quality of Life measured by the PedsQL Cancer Module [Time frame: up to 18 months]
• Subject adherence to exercise regimen [Time frame: up to 18 months]
• Adverse Events Related to Exercise Program [Time frame: up to 18 months]

Eligibility criteria

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 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
• Subject has newly diagnosed cancer per Investigator and is planning to undergo chemotherapy, immunotherapy, or other systemically delivered for treatment of malignancy. Subjects are allowed to be enrolled up to 21 days after initiating cancer treatment.
• Receiving oncologic care at Levine Children's Cancer and Blood Disorders Clinic.
• Subject is anticipated to receive at least 3 full cycles of chemotherapy or other systemic cancer treatment.
• Not participating in another clinical trial that precludes participating in additional nondrug clinical trials.

Exclusion criteria

• 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
• Osteosarcoma

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Levine Children's Hospital — Charlotte

Identifiers

NCT: NCT05058508 · IRB00082746 · LCI-PED-NOS-EXER-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗