Clinical trial NCT05823740: Measuring Changes in Body Composition and Physical Function in Patients With Childhood Cancers
Official title: Measuring Changes in Body Composition and Physical Function in Patients With Childhood Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Malignant Neoplasm
Keywords: D3-creatine dilution method
pediatric
muscle mass
biological aging
physical function
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: The feasibility of collecting body composition assessments
timeFrame: up to 12 months
measure: The feasibility of collecting individual physical function assessments
timeFrame: up to 12 months
Secondary outcomes:
measure: Feasibility of collecting repeated measurements of biological aging (p16 expression)
timeFrame: up to 12 months
measure: The acceptability of the study
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Andrew Smitherman
role: PRINCIPAL_INVESTIGATOR
References: