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NCT Number: NCT05058508

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

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.

Recruiting

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Key information

Age range

2 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Levine Children's Hospital

Charlotte, North Carolina, 28203, United States

Location status: Recruiting

Location contact

Jennifer Pope, MD

PRINCIPAL_INVESTIGATOR

Meg Lattanze

CONTACT

[email protected]

980-442-4239

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"Just Move" Exercise

Other

Subjects complete "Just Move" Exercises Five Times Per Week

Standard of care exercise

Other

Subjects exercise/move as tolerated

Primary outcomes

  1. Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment

    Time frame: 18 month period

    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

  2. Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment

    Time frame: 18 month period

    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).

Secondary outcomes

  1. Adverse Event Rate

    Time frame: up to 18 months

    Occurrence of Adverse Events of Special Interest (thromboembolic event, skin ulceration, significant nausea/vomiting, and constipation) will be measured as binary variables.

  2. Quality of Life measured by the PedsQL Cancer Module

    Time frame: up to 18 months

    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).

  3. Subject adherence to exercise regimen

    Time frame: up to 18 months

    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.

  4. Adverse Events Related to Exercise Program

    Time frame: up to 18 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Meg Lattanze

CONTACT

[email protected]

(980) 442-4239

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Atrium Health Levine Cancer Institute

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 27, 2021
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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