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NCT05823740 | RECRUITING | Cancer

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

UNC Lineberger Comprehensive Cancer Center

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

Cancer

Malignant Neoplasm

Intervention/treatment

Bioelectrical impedance Analysis (BIA)

D3-Creatine Dilution (D3Cr)

6-Minute Walk Test (6MWT)

Timed Up and Go (TUG)

30-second Sit-to-Stand (STS)

Hand Grip Strength (GS)

PBTL p16 expression

CT, MR and PET Imaging

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Measuring Changes in Body Composition and Physical Function in Patients With Childhood Cancers
Actual Study Start Date : 2023-05-01
Estimated Primary Completion Date : 2026-01-30
Estimated Study Completion Date : 2026-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 8 Years to 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
    • Measuring Changes in Body Composition and Physical Function in Patients With Childhood Cancers

    Location Details

    NCT05823740

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, North Carolina

    UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, United States, 27514