Body Composition and Setup Errors in Radiotherapy
ConditionMalignant Neoplasms
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShijiazhuang People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically confirmed malignancy
Age ≥18 years
Receiving radical or adjuvant intensity-modulated radiotherapy (IMRT) with planned ≥25 fractions
Immobilized with thermoplastic mask
Disqualifiers
Metal implants (pacemaker, artificial joints) affecting bioelectrical impedance analysis (BIA) measurements
Severe edema or ascites
Inability to cooperate with immobilization or CBCT scanning
Radiotherapy interruption >5 fractions
Trial population
Patients with pathologically confirmed malignancies receiving radical or adjuvant intensity-modulated radiotherapy at Shijiazhuang People's Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 2 trial groupsGroup A: High Muscle Mass Group
Group B: Low Muscle Mass Group
Trial outcomes
Primary outcomes
1
setup errors
Six-degree-of-freedom setup errors (Tx, Ty, Tz, Rx, Ry, Rz) measured by cone-beam computed tomography (CBCT).
Time frame
Through study completion, an average of 6 months.Secondary outcomes
1
Change in Skeletal Muscle Mass
Change in skeletal muscle mass (SMM) from baseline (T0) to radiotherapy fraction 20 (T1), measured by multi-frequency bioelectrical impedance analysis (BIA). SMM is expressed in kilograms (kg).
Time frame
Baseline and fraction 20 (approximately 4 weeks after baseline)2
Change in Body Fat Percentage
Change in body fat percentage (BFP) from baseline (T0) to radiotherapy fraction 20 (T1), measured by multi-frequency bioelectrical impedance analysis (BIA). BFP is expressed as a percentage (%).
Time frame
Baseline and fraction 20 (approximately 4 weeks after baseline).3
Change in Phase Angle
Change in phase angle (PhA) from baseline (T0) to radiotherapy fraction 20 (T1), measured by multi-frequency bioelectrical impedance analysis (BIA). PhA is expressed in degrees (°).
Time frame
Baseline and fraction 20 (approximately 4 weeks after baseline)4
Change in Fat-Free Mass
Change in fat-free mass (FFM) from baseline (T0) to radiotherapy fraction 20 (T1), measured by multi-frequency bioelectrical impedance analysis (BIA). FFM is expressed in kilograms (kg).
Time frame
Baseline and fraction 20 (approximately 4 weeks after baseline)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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