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

UNC Lineberger Comprehensive Cancer Center

Status: Enrolling

Conditions: Malignant Neoplasm; Cancer

Treatments: Other: Hand Grip Strength (GS); Other: D3-Creatine Dilution (D3Cr); Other: PBTL p16 expression; Other: 6-Minute Walk Test (6MWT); Other: 30-second Sit-to-Stand (STS); Other: Timed Up and Go (TUG); Other: Bioelectrical impedance Analysis (BIA); Other: CT, MR and PET Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT05823740

LCCC2232

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 8 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Single Arm

Other group

Description:

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

Treatment:

Other: CT, MR and PET Imaging

Other: Bioelectrical impedance Analysis (BIA)

Other: Timed Up and Go (TUG)

Other: 30-second Sit-to-Stand (STS)

Other: 6-Minute Walk Test (6MWT)

Other: PBTL p16 expression

Other: D3-Creatine Dilution (D3Cr)

Other: Hand Grip Strength (GS)