CancerNCT05823740
Measuring Changes in Body Composition and Physical Function in Patients With Childhood Cancers
A study testing Bioelectrical impedance Analysis (BIA), D3-Creatine Dilution (D3Cr) and 6-Minute Walk Test (6MWT) in people with Cancer and Malignant Neoplasm, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Cancer, Malignant Neoplasm
- What is being tested?
- Bioelectrical impedance Analysis (BIA), D3-Creatine Dilution (D3Cr) and 6-Minute Walk Test (6MWT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 21 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
About this study
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
- Being tested
- Bioelectrical impedance Analysis (BIA), D3-Creatine Dilution (D3Cr), 6-Minute Walk Test (6MWT), Timed Up and Go (TUG), 30-second Sit-to-Stand (STS)
- Keywords
- D3-creatine dilution method, pediatric, muscle mass, biological aging, physical function
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 expressionOther
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 ImagingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Children with malignant diseases, receiving anti-cancer treatment and completed study interventions. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: up to 12 months
Secondary outcomes (2)
Feasibility of collecting repeated measurements of biological aging (p16 expression)
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.
Measured: up to 12 months
The acceptability of the study
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.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 May 2023
- Primary completion21 Feb 2026
- Study completion21 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Smitherman, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823740
- Sponsor's protocol ID
- LCCC2232
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data may be made available on an individual basis at the discretion of the PI.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Changes in Body Composition and Physical Function in Patients With Childhood Cancers
- ClinicalTrials.gov ID
- NCT05823740
- Acronym / sponsor ID
- LCCC2232
- Conditions
- Cancer, Malignant Neoplasm
- Keywords
- D3-creatine dilution method, pediatric, muscle mass, biological aging, physical function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 21 Feb 2026 (actual)
- Study completion
- 21 Feb 2026 (actual)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | 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 ImagingChildren with malignant diseases, receiving anti-cancer treatment and completed study interventions. |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Single Arm |
| 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. | Other | Single Arm |
| 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. | Other | Single Arm |
| 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. | Other | Single Arm |
| 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. | Other | Single Arm |
| 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. | Other | Single Arm |
| PBTL p16 expressionPeripheral 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. | Other | Single Arm |
| CT, MR and PET ImagingParticipants 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. | Other | Single Arm |
Primary outcome
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).
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.
2 secondary outcomes
Feasibility of collecting repeated measurements of biological aging (p16 expression)
Time frame: up to 12 months
The acceptability of the study
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data may be made available on an individual basis at the discretion of the PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Smitherman principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioelectrical impedance Analysis (BIA), D3-Creatine Dilution (D3Cr) and 6-Minute Walk Test (6MWT) in people with Cancer and Malignant Neoplasm, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of collecting body composition assessments (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.