ClinConnect ClinConnect Logo
Search / Trial NCT05823740

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

Launched by UNC LINEBERGER COMPREHENSIVE CANCER CENTER · Apr 10, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

D3 Creatine Dilution Method Pediatric Muscle Mass Biological Aging Physical Function

ClinConnect Summary

This clinical trial is focused on understanding how cancer treatment affects the body composition and physical function of children and young adults diagnosed with certain types of cancer, specifically malignant solid tumors or lymphoma. Researchers want to see how well they can measure changes in lean muscle mass, physical function, and biological aging during the treatment process. They will use a special method called D3-creatine dilution to check skeletal muscle mass. Assessments will take place at the time of diagnosis, during treatment, and at the end of treatment, alongside regular imaging scans like CT or MRI.

To be eligible for this study, participants must be between the ages of 8 and 21 and have a newly diagnosed malignant tumor or lymphoma. They should be getting treatment like chemotherapy or radiation and must be able to speak English or Spanish. If they join, participants can expect to undergo several measurements and tests to help researchers learn more about how cancer therapy impacts their bodies. It’s important to note that those with a history of cancer or certain medical conditions may not be able to participate. This study aims to improve the understanding of cancer's effects on young patients and assess the feasibility of new measurement techniques.

Gender

ALL

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.

About Unc Lineberger Comprehensive Cancer Center

The UNC Lineberger Comprehensive Cancer Center is a leading research institution dedicated to advancing cancer treatment and prevention through innovative clinical trials and comprehensive patient care. As a National Cancer Institute-designated comprehensive cancer center, it integrates cutting-edge research, interdisciplinary collaboration, and patient-centered approaches to address diverse oncology challenges. With a commitment to translating scientific discoveries into effective therapies, UNC Lineberger strives to improve outcomes for patients while fostering a robust environment for education and training in cancer research.

Locations

Chapel Hill, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Andrew Smitherman

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported