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NCT Number: NCT07676032

Body Composition and Setup Errors in Radiotherapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Radiotherapy is a cornerstone of cancer treatment, with approximately 50-70% of patients requiring radiotherapy during their disease course. Accurate patient positioning is essential for ensuring adequate target volume coverage while sparing organs at risk. Thermoplastic masks are among the most commonly used immobilization devices; however, setup reproducibility varies considerably among patients. Previous studies have demonstrated that patients with BMI ≥24 kg/m² exhibit significantly greater setup errors across multiple directions in breast, cervical, and thoracic cancers compared with normal-weight patients. However, BMI is a crude anthropometric measure that cannot distinguish between fat and muscle mass-two tissue types with fundamentally different mechanical properties that may affect mask fit and positional reproducibility. Bioelectrical impedance analysis (BIA) provides a non-invasive, convenient method for measuring body composition parameters, including skeletal muscle mass (SMM), body fat percentage (BFP), phase angle (PhA), and fat-free mass (FFM). Phase angle, in particular, reflects cell membrane integrity and cellular mass, and has been validated as a sensitive marker of muscle quality and nutritional status in cancer patients. However, the value of BIA-derived body composition parameters in predicting radiotherapy setup errors has not been systematically explored. This study is a single-center, prospective observational cohort study conducted at the Department of Radiation Oncology, Shijiazhuang People's Hospital, China. A total of 120-150 patients with pathologically confirmed malignancies receiving radical or adjuvant intensity-modulated radiotherapy (≥25 fractions) with thermoplastic mask immobilization will be enrolled. Body composition parameters will be measured using BIA at baseline (T0) and at fraction 20 (T1). Setup errors (six degrees of freedom: Tx, Ty, Tz, Rx, Ry, Rz) will be recorded via cone-beam computed tomography (week 1: 3 times; thereafter: weekly). The primary outcome is the association between baseline body composition parameters and setup errors. Secondary outcomes include the relationship between body composition changes and setup error evolution, and identification of threshold values for clinically significant setup error increases. Data will be analyzed using multiple linear regression and generalized estimating equations. Results will be disseminated through peer-reviewed publications and conference presentations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. setup errors

    Time frame: Through study completion, an average of 6 months.

    Six-degree-of-freedom setup errors (Tx, Ty, Tz, Rx, Ry, Rz) measured by cone-beam computed tomography (CBCT).

Secondary outcomes

  1. Change in Skeletal Muscle Mass

    Time frame: Baseline and fraction 20 (approximately 4 weeks after baseline)

    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).

  2. Change in Body Fat Percentage

    Time frame: Baseline and fraction 20 (approximately 4 weeks after baseline).

    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 (%).

  3. Change in Phase Angle

    Time frame: Baseline and fraction 20 (approximately 4 weeks after baseline)

    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 (°).

  4. Change in Fat-Free Mass

    Time frame: Baseline and fraction 20 (approximately 4 weeks after baseline)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Chaoxing Liu, Dr

CONTACT

[email protected]

86 17603119780

Xiaoyan Wang, Dr

CONTACT

[email protected]

86 15031163260

Sponsors and collaborators

Lead sponsor

Shijiazhuang People's Hospital

Other

Registry information

Official study title

The Impact of Body Composition on Setup Errors in Patients Undergoing Radiotherapy With Thermoplastic Mask Immobilization: A Single-Center Prospective Cohort Study

Acronym: BODY-SET

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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