Clinical trial · Observational
Body Composition and Setup Errors in Radiotherapy
The Impact of Body Composition on Setup Errors in Patients Undergoing Radiotherapy With Thermoplastic Mask Immobilization: A Single-Center Prospective Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasms | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- High Muscle Mass Group
- description
- Patients with skeletal muscle mass above the sex-specific median
- label
- Low Muscle Mass Group
- description
- Patients with skeletal muscle mass below the sex-specific median
Primary outcomes (1)
- measure
- setup errors
- timeFrame
- Through study completion, an average of 6 months.
- description
- Six-degree-of-freedom setup errors (Tx, Ty, Tz, Rx, Ry, Rz) measured by cone-beam computed tomography (CBCT).
Secondary outcomes (4)
- measure
- Change in Skeletal Muscle Mass
- timeFrame
- Baseline and fraction 20 (approximately 4 weeks after baseline)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed malignancy * Age ≥18 years * Receiving radical or adjuvant intensity-modulated radiotherapy (IMRT) with planned ≥25 fractions * Immobilized with thermoplastic mask * ECOG Performance Status 0-2 * Willing and able to provide written informed consent Exclusion Criteria: * 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 * Pregnancy or lactation
References
Publications (16)
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