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

NCT05823740 | Completed DMC

• 1 other identifier: LCCC2232
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

D3-creatine dilution method; pediatric; muscle mass; biological aging; physical function

Outcome Measures

Primary Outcomes (2)

• The feasibility of collecting body composition assessments

  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

  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 Outcomes (2)

• Feasibility of collecting repeated measurements of biological aging (p16 expression)

  up to 12 months

• The acceptability of the study

  up to 12 months

Study Arms (1)

Single Arm

OTHER

Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.

Other: Bioelectrical impedance Analysis (BIA); Other: D3-Creatine Dilution (D3Cr); Other: 6-Minute Walk Test (6MWT); Other: Timed Up and Go (TUG); Other: 30-second Sit-to-Stand (STS); Other: Hand Grip Strength (GS); Other: PBTL p16 expression; Other: CT, MR and PET Imaging

Interventions

Bioelectrical impedance Analysis (BIA) OTHER

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.

Single Arm

D3-Creatine Dilution (D3Cr) OTHER

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.

Single Arm

6-Minute Walk Test (6MWT) OTHER

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.

Single Arm

Timed Up and Go (TUG) OTHER

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.

Single Arm

30-second Sit-to-Stand (STS) OTHER

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.

Single Arm

Hand Grip Strength (GS) OTHER

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.

Single Arm

PBTL p16 expression OTHER

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.

Single Arm

CT, MR and PET Imaging OTHER

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.

Single Arm

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 8-21 years at the time of cancer diagnosis
• Must have a newly diagnosed malignant solid tumor or lymphoma.
• Participant is expected to undergo cancer treatment with either chemotherapy, radiation, immunotherapy, or other biologically targeted therapy.
• 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.
• Written informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information.
• English or Spanish speaking
• Subject is willing and able to comply with study procedures.
• Since the patient is undergoing active cancer therapy, must obtain approval from the treating physician.

You may not qualify if:

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Neoplasms

Interventions

Hand Strength; Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Muscle Strength; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Andrew Smitherman

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 21, 2023
• Study Start: May 1, 2023
• Primary Completion: February 21, 2026
• Study Completion: February 21, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)