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

Summary

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.

Conditions

• Cancer
• Malignant Neoplasm

Interventions

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.

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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Andrew Smitherman · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

8 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-01

Primary Completion

2026-02-21

Completion

2026-02-21

Countries

• United States

Study Locations