Measuring body composition and physical function in children with cancer
Measuring Changes in Body Composition and Physical Function in Patients With Childhood Cancers
This study is testing how to measure muscle mass and physical abilities in children with cancer during their treatment to see how their bodies are changing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 8 Years to 21 Years |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT05823740 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and acceptability of measuring lean muscle mass, physical function, and biological aging in children undergoing active cancer therapy. It utilizes the D3-creatine dilution method to assess skeletal muscle mass at various stages of treatment, including diagnosis, during treatment, and at the end of treatment. Assessments will be coordinated with routine imaging to monitor changes in these outcomes. Key sociodemographic and health-related factors will also be collected from medical records.
Who should consider this trial
Good fit: Ideal candidates are children aged 8-21 years with newly diagnosed malignant solid tumors or lymphomas who are beginning cancer treatment.
Not a fit: Patients who are not undergoing active cancer therapy or do not meet the age and diagnosis criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the physical health and recovery of children undergoing cancer treatment, potentially leading to improved care strategies.
How similar studies have performed: Other studies have shown success in measuring body composition and physical function in pediatric cancer patients, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Chapel Hill, North Carolina
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Andrew Smitherman — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Daniel Kleissler
- Email: daniel_kleissler@med.unc.edu
- Phone: 919-928-6231
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.