Measuring Changes in Body Composition and Physical Function in Patients With Childhood Cancers
NCT ID: NCT05823740
Last Updated: 2025-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2023-05-01
2026-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Single Arm
Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
8 Years
21 Years
ALL
No
Sponsors
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UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Andrew Smitherman
Role: PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Locations
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UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
Other Identifiers
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LCCC2232
Identifier Type: -
Identifier Source: org_study_id
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