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

Sponsor

UNC Lineberger Comprehensive Cancer Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05823740

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Malignant Neoplasm	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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Apr 30, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Single Arm Children with malignant diseases, receiving anti-cancer treatment and completed study interventions.	Other: 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: 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: 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: 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: 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: 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: 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. Other: 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.

Arm

Intervention/Treatment

Other: Single Arm

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

Other: 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: 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: 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: 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: 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: 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: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

The feasibility of collecting body composition assessments [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 [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 Outcome Measures

Feasibility of collecting repeated measurements of biological aging (p16 expression) [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.
The acceptability of the study [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.