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

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.

Bioelectrical impedance Analysis (BIA)

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.

D3-Creatine Dilution (D3Cr)

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.

6-Minute Walk Test (6MWT)

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.

Timed Up and Go (TUG)

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.

30-second Sit-to-Stand (STS)

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.

Hand Grip Strength (GS)

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.

PBTL p16 expression

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.

CT, MR and PET Imaging

Daniel Kleissler

Jessica Benjamin-Eze, DO

Jessica Benjamin-Eze

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.

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

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

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).

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Measuring Changes in Body Composition and Physical Function in Patients With Childhood Cancers	NCT05823740	Cancer Malignant Neopl...	Bioelectrical i... D3-Creatine Dil... 6-Minute Walk T... Timed Up and Go... 30-second Sit-t... Hand Grip Stren... PBTL p16 expres... CT, MR and PET ...	8 Years - 21 Years	UNC Lineberger Comprehensive Cancer Center
Measuring Changes in Body Composition and Physical Function in Patients With Childhood Cancers	NCT05823740	Cancer Malignant Neopl...	Bioelectrical i... D3-Creatine Dil... 6-Minute Walk T... Timed Up and Go... 30-second Sit-t... Hand Grip Stren... PBTL p16 expres... CT, MR and PET ...	8 Years - 21 Years	UNC Lineberger Comprehensive Cancer Center

Spots Global Cancer Trial Database for pbtl p16 expression