Clinical Trial

Body Composition and Setup Errors in Radiotherapy

Study acronym: BODY-SET
Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
This single-center prospective cohort study investigates the association between body composition parameters and setup errors in 120-150 patients receiving radiotherapy with thermoplastic mask immobilization. Body composition (skeletal muscle mass, body fat percentage, phase angle, fat-free mass) will be measured using bioelectrical impedance analysis at baseline and at fraction 20. Setup errors (six degrees of freedom) will be recorded via daily cone-beam computed tomography. The primary outcome is the association between baseline body composition and setup errors. Secondary outcomes include the relationship between body composition changes during radiotherapy and setup error evolution, and identification of threshold values for clinically significant setup error increases. This study will provide evidence on whether body composition-beyond BMI-predicts radiotherapy setup accuracy, potentially enabling personalized immobilization and image-guided strategies.
Trial Details
NCT Number NCT07676032
Lead Sponsor Shijiazhuang People's Hospital
Conditions Malignant Neoplasms
Enrollment 150 participants
Start Date 2026-07-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-30