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Completed

NCT Number: NCT05823740

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

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.

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Key information

Conditions

Cancer Malignant Neoplasm Neoplasms

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

  • 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.

Exclusion criteria

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

  • 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.

Treatment and study plan

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.

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.

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.

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.

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.

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.

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.

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.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2023
Registry last updated
May 1, 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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