Body Composition and Setup Errors in Radiotherapy

Official title

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

Overview

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.

Detailed description

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.

Primary outcome measures

• setup errors [Time frame: Through study completion, an average of 6 months.]

Secondary outcome measures (4)

• Change in Skeletal Muscle Mass [Time frame: Baseline and fraction 20 (approximately 4 weeks after baseline)]
• Change in Body Fat Percentage [Time frame: Baseline and fraction 20 (approximately 4 weeks after baseline).]
• Change in Phase Angle [Time frame: Baseline and fraction 20 (approximately 4 weeks after baseline)]
• Change in Fat-Free Mass [Time frame: Baseline and fraction 20 (approximately 4 weeks after baseline)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586. PMID 23303884
• Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583. PMID 23295957
• Kecojevic A, Ranken R, Ecker DJ, Massire C, Sampath R, Blyn LB, Hsieh YH, Rothman RE, Gaydos CA. Rapid PCR/ESI-MS-based molecular genotyping of Staphylococcus aureus from nasal swabs of emergency department patients. BMC Infect Dis. 2014 Jan 9;14:16. doi: 10.1186/1471-2334-14-16. PMID 24405766
• Polack S, Adams M, O'banion D, Baltussen M, Asante S, Kerac M, Gladstone M, Zuurmond M. Children with cerebral palsy in Ghana: malnutrition, feeding challenges, and caregiver quality of life. Dev Med Child Neurol. 2018 Sep;60(9):914-921. doi: 10.1111/dmcn.13797. Epub 2018 May 7. PMID 29736993
• Dai X, Feng J, Chen Y, Huang S, Shi X, Liu X, Sun Y. Traditional Chinese Medicine in nonalcoholic fatty liver disease: molecular insights and therapeutic perspectives. Chin Med. 2021 Aug 3;16(1):68. doi: 10.1186/s13020-021-00469-4. PMID 34344394
• Dou S, Ding H, Jiang W, Li R, Qian Y, Wu S, Ling Y, Zhu G. Effect of oral supplements on the nutritional status of nasopharyngeal carcinoma patients undergoing concurrent chemotherapy: A randomized controlled Phase II trial. J Cancer Res Ther. 2020;16(7):1678-1685. doi: 10.4103/jcrt.JCRT_273_20. PMID 33565516
• Kohli K, Corns R, Vinnakota K, Steiner P, Elith C, Schellenberg D, Kwan W, Karvat A. A bioimpedance analysis of head-and-neck cancer patients undergoing radiotherapy. Curr Oncol. 2018 Jun;25(3):e193-e199. doi: 10.3747/co.25.3920. Epub 2018 Jun 28. PMID 29962845
• Toussaint ND, Pedagogos E, Lioufas NM, Elder GJ, Pascoe EM, Badve SV, Valks A, Block GA, Boudville N, Cameron JD, Campbell KL, Chen SSM, Faull RJ, Holt SG, Jackson D, Jardine MJ, Johnson DW, Kerr PG, Lau KK, Hooi LS, Narayan O, Perkovic V, Polkinghorne KR, Pollock CA, Reidlinger D, Robison L, Smith ER, Walker RJ, Wang AYM, Hawley CM; IMPROVE-CKD Trial Investigators. A Randomized Trial on the Effec PMID 32917784

Identifiers

NCT: NCT07676032 · SJZPH-RO-2026-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗