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Trial Title:
Measuring Changes in Body Composition and Physical Function in Patients With Childhood Cancers
NCT ID:
NCT05823740
Condition:
Cancer
Malignant Neoplasm
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
D3-creatine dilution method
pediatric
muscle mass
biological aging
physical function
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Bioelectrical impedance Analysis (BIA)
Description:
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.
Arm group label:
Single Arm
Intervention type:
Other
Intervention name:
D3-Creatine Dilution (D3Cr)
Description:
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.
Arm group label:
Single Arm
Intervention type:
Other
Intervention name:
6-Minute Walk Test (6MWT)
Description:
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.
Arm group label:
Single Arm
Intervention type:
Other
Intervention name:
Timed Up and Go (TUG)
Description:
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.
Arm group label:
Single Arm
Intervention type:
Other
Intervention name:
30-second Sit-to-Stand (STS)
Description:
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.
Arm group label:
Single Arm
Intervention type:
Other
Intervention name:
Hand Grip Strength (GS)
Description:
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.
Arm group label:
Single Arm
Intervention type:
Other
Intervention name:
PBTL p16 expression
Description:
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.
Arm group label:
Single Arm
Intervention type:
Other
Intervention name:
CT, MR and PET Imaging
Description:
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.
Arm group label:
Single Arm
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria In order to participate in this study a subject must meet all of the
eligibility criteria outlined below.
1. Ages 8-21 years at the time of cancer diagnosis
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 All subjects meeting any exclusion criteria at baseline will be
excluded from study participation.
1. Prior history of cancer
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.
Gender:
All
Minimum age:
8 Years
Maximum age:
21 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
UNC Lineberger Comprehensive Cancer Center
Address:
City:
Chapel Hill
Zip:
27514
Country:
United States
Status:
Recruiting
Contact:
Last name:
Daniel Kleissler
Phone:
919-928-6231
Email:
daniel_kleissler@med.unc.edu
Investigator:
Last name:
Jessica Benjamin-Eze, DO
Email:
Principal Investigator
Start date:
May 1, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05823740
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
