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

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ClinicalTrials.gov Identifier: NCT05058508
Recruitment Status : Not yet recruiting
First Posted : September 27, 2021
Last Update Posted : September 27, 2021
Sponsor:
Information provided by (Responsible Party):
Jamie Mochel, Atrium Health

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
Pediatric Cancer Other: "Just Move" Exercise Other: Standard of Care Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment [ Time Frame: 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 [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05058508


Contacts
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Contact: Devika Srivastava 704-355-2000 devika.srivastava@atriumhealth.org

Sponsors and Collaborators
Jamie Mochel
Investigators
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Principal Investigator: Jamie Mochel, MSN, CPNP-AC Atrium Health
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Responsible Party: Jamie Mochel, Principal Investigator, Atrium Health
ClinicalTrials.gov Identifier: NCT05058508    
Other Study ID Numbers: LCI-PED-NOS-EXER-001
First Posted: September 27, 2021    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No