Measuring Changes in Body Composition and Physical Function in Patients With Childhood Cancers

April 30, 2026 updated by: UNC Lineberger Comprehensive Cancer Center

The primary objective of this study is to evaluate the feasibility and acceptability of obtaining repeated measurements of lean muscle mass, physical function, and biological aging in children receiving active cancer therapy. The secondary objective is to evaluate the feasibility of using the D3-creatine dilution method (D3Cr) to measure skeletal muscle mass in children with cancer.

Assessments will be collected at diagnosis, once during active treatment, and end of treatment in coordination with routine imaging to monitor changes in study outcomes during active cancer treatment. Key sociodemographic, treatment and health-related factors will be abstracted from the medical record.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Lineberger Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

  1. Ages 8-21 years at the time of cancer diagnosis
  2. Must have a newly diagnosed malignant solid tumor or lymphoma.
  3. Participant is expected to undergo cancer treatment with either chemotherapy, radiation, immunotherapy, or other biologically targeted therapy.
  4. Participants will undergo routine imaging with either computed tomography (CT), or Magnetic Resonance Imaging (MRI) of the chest or abdomen, or whole-body positron emission tomography (PET) scan.
  5. Written informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information.
  6. English or Spanish speaking
  7. Subject is willing and able to comply with study procedures.
  8. Since the patient is undergoing active cancer therapy, must obtain approval from the treating physician.

Exclusion Criteria All subjects meeting any exclusion criteria at baseline will be excluded from study participation.

  1. Prior history of cancer
  2. Treatment with surgical excision alone
  3. Planned palliative treatment.
  4. Subject has elected to forgo chemotherapy or radiotherapy.
  5. Any diagnosis of leukemia.
  6. Clinical concerns that the treating clinician feels would preclude participation in the study.
  7. Subject has a pacemaker or bilateral joint prosthesis that would prevent undergoing BIA assessment.
  8. Unwilling to sign informed consent.
  9. Speak a language other than English or Spanish.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm
Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.
Other: Bioelectrical impedance Analysis (BIA)
Bioelectrical impedance analysis (BIA) is a method for estimating body composition, in particular, body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate the impedance (resistance) of the body. BIA will be done at baseline, during the study related to routine medical imaging, and end of the study.
Other: D3-Creatine Dilution (D3Cr)
The D3-Creatine dilution method is a safe and noninvasive measure of skeletal muscle mass that has previously been validated in adults, neonates, healthy children, and children. D3-Creatine Dilution will be done at baseline, during the study related to routine medical imaging, and end of the study.
Other: 6-Minute Walk Test (6MWT)
Cardiovascular fitness will be measured with the 6-minute walk test (6MWT). 6MWT will be done at baseline, during the study related to routine medical imaging, and end of the study.
Other: Timed Up and Go (TUG)
Balance and mobility will be assessed by the timed-up-and-go test (TUG). TUG will be done at baseline, during the study related to routine medical imaging, and end of the study.
Other: 30-second Sit-to-Stand (STS)
Strength and muscular function will be evaluated by modified 30-second sit-to-stand (STS). STS will be done at baseline, during the study related to routine medical imaging, and end of the study.
Other: Hand Grip Strength (GS)
Strength and muscular function will be evaluated by grip strength (GS). GS will be done at baseline, during the study related to routine medical imaging, and end of the study.
Other: PBTL p16 expression
Peripheral Blood biospecimen for PBTL p16 expression will be used for the assessment of biological aging. Blood biospecimens will be collected at baseline and end of the study for PBTL p16 analysis.
Other: CT, MR and PET Imaging
Participants will undergo routine imaging with either computed tomography (CT), Magnetic Resonance Imaging (MRI) of the chest or abdomen, or whole-body positron emission tomography (PET) scan. Skeletal muscle mass and fat mass will be calculated at several different vertebral levels from imaging studies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The feasibility of collecting body composition assessments
Time Frame: up to 12 months
The feasibility of collecting body composition assessments will be measured as the % of participants completing all 3 assessments for each modality: D3-Creatine dilution method (D3Cr), Bioelectrical impedance Analysis (BIA), medical imaging (computerized tomography (CT), or magnetic resonance imaging (MRI), or positron emission tomography (PET).
up to 12 months
The feasibility of collecting individual physical function assessments
Time Frame: up to 12 months
The feasibility of collecting individual physical function assessments will be measured as the % of participants completing all 3 assessments for each modality namely the 6-Minute Walk Test (6MWT), Timed Up and Go (TUG), 30-second Sit-to-Stand (STS), Hand Grip Strength (GS)) at multiple time points during cancer therapy.
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of collecting repeated measurements of biological aging (p16 expression)
Time Frame: up to 12 months
The feasibility of collecting repeated measurements of biological aging (p16 expression) will be evaluated as % of participants completed both pre-treatment and post-treatment assessments.
up to 12 months
The acceptability of the study
Time Frame: up to 12 months
The acceptability of the study will be evaluated as the number of subjects approached and enrolled and number of subjects that withdraw from the study.
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Investigators

  • Principal Investigator: Andrew Smitherman, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

February 21, 2026

Study Completion (Actual)

February 21, 2026

Study Registration Dates

First Submitted

April 10, 2023

First Submitted That Met QC Criteria

April 10, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC2232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data may be made available on an individual basis at the discretion of the PI.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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