This clinical trial evaluates how body composition (muscle mass) and physical function (strength, mobility, endurance) changes and how best to measure these changes in patients with childhood malignant solid tumors and lymphoma undergoing cancer treatment. Children and young adults with cancer often experience weight loss, muscle loss, weakness, and fatigue due to cancer and its associated treatments. It is common for these undesirable changes to last well into adulthood and can lead to long term medical problems such as diabetes, high blood pressure, and high cholesterol at a younger age. This study tests a newer and non-invasive way to measure muscle (D3-creatine dilution). This method can be completed in many settings (clinic, home, hospital) and may allow for better tracking of muscle loss experienced by childhood cancer patients during active treatment. Bioelectric impedance analysis (BIA) is a method to assess body composition. Information from this study may help childhood cancer doctors better understand the physical changes children with cancer experience during treatment and provide critical information about when and how we can intervene to limit or prevent these problematic changes.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05823740.
PRIMARY OBJECTIVES:
I. Evaluate the feasibility of collecting repeated measures of body composition using assessments of Deuterium-creatine dilution method (D3Cr), BIA, and computed tomography (CT)/magnetic resonance imaging (MRI) at multiple time points during cancer therapy.
II. Evaluate the feasibility of collecting repeated measures of physical function using assessments of six-minute walk test (6MWT), timed up and go (TUG), 30 second sit to stand (STS), hand grip strength (GS) at multiple time points during cancer therapy.
SECONDARY OBJECTIVES:
I. Evaluate the feasibility of collecting repeated measurements of biological age (p16 expression) pre-treatment and post-treatment.
II. Evaluate the acceptability based on the number of subjects approached and enrolled and number of subjects that withdraw.
EXPLORATORY OBJECTIVES:
I. To measure changes in lean muscle mass and physical function from diagnosis to end of treatment.
II. To measure changes in physical function from diagnosis to end of treatment.
III. To describe the association between changes in skeletal muscle mass and changes in physical function during active cancer treatment.
IV. To measure change in peripheral blood T-lymphocyte (PBTL) p16 expression from diagnosis to end of treatment.
V. To measure the association between changes in p16 expression and changes in skeletal muscle mass.
VI. To measure the association between changes in p16 expression and changes in physical function (physiologic aging).
OUTLINE:
Patients undergo body composition measurements using computed tomography (CT)/magnetic resonance imaging (MRI) imaging, BIA, and D3Cr and physical function tests. Patients also undergo collection of blood samples and have their medical records reviewed.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorAndrew Brian Smitherman
