Body Composition and Setup Errors in Radiotherapy

NCT07676032 | Not Yet Recruiting

• 1 other identifier: SJZPH-RO-2026-001
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Malignant Neoplasms

Keywords

Bioelectrical Impedance Analysis; Setup Errors; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• setup errors

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

  Through study completion, an average of 6 months.

Secondary Outcomes (4)

• Change in Skeletal Muscle Mass

  Baseline and fraction 20 (approximately 4 weeks after baseline)

• Change in Body Fat Percentage

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

• Change in Phase Angle

  Baseline and fraction 20 (approximately 4 weeks after baseline)

• Change in Fat-Free Mass

  Baseline and fraction 20 (approximately 4 weeks after baseline)

Study Arms (2)

High Muscle Mass Group

Patients with skeletal muscle mass above the sex-specific median

Low Muscle Mass Group

Patients with skeletal muscle mass below the sex-specific median

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with pathologically confirmed malignancies receiving radical or adjuvant intensity-modulated radiotherapy at Shijiazhuang People's Hospital.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shijiazhuang People's Hospital: lead

Related Publications (16)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 Effect of Phosphate Reduction on Vascular End Points in CKD (IMPROVE-CKD). J Am Soc Nephrol. 2020 Nov;31(11):2653-2666. doi: 10.1681/ASN.2020040411. Epub 2020 Sep 11.

  PMID: 32917784 BACKGROUND

• Bas D, Atahan C, Tezcanli E. An analysis of phase angle and standard phase angle cut-off values and their association with survival in head and neck cancer patients undergoing radiotherapy. Clin Nutr. 2023 Aug;42(8):1445-1453. doi: 10.1016/j.clnu.2023.06.020. Epub 2023 Jul 6.

  PMID: 37451156 BACKGROUND

• Prior-Sanchez I, Herrera-Martinez AD, Zarco-Martin MT, Fernandez-Jimenez R, Gonzalo-Marin M, Munoz-Garach A, Vilchez-Lopez FJ, Cayon-Blanco M, Villarrubia-Pozo A, Munoz-Jimenez C, Zarco-Rodriguez FP, Rabat-Restrepo JM, Luengo-Perez LM, Boughanem H, Martinez-Ramirez MJ, Garcia-Almeida JM. Prognostic value of bioelectrical impedance analysis in head and neck cancer patients undergoing radiotherapy: a VALOR(R) study. Front Nutr. 2024 Feb 22;11:1335052. doi: 10.3389/fnut.2024.1335052. eCollection 2024.

  PMID: 38463940 BACKGROUND

• Chen J, Guo Y, Wang C, Lin S, Shao L, Lan L, Guo F. Univariate and multivariate analysis of the styrofoam fixation device on patient setup errors in radiotherapy. J Appl Clin Med Phys. 2025 Jul;26(7):e70181. doi: 10.1002/acm2.70181.

  PMID: 40660902 BACKGROUND

• Ruan J, Huang X, Wang T, Mai X, Lin C, Li F, Li Y, Chi F, Li B. Impact of belly board immobilization devices and body mass factor on setup displacement using daily cone-beam CT in rectal cancer radiotherapy. J Appl Clin Med Phys. 2025 Mar;26(3):e14573. doi: 10.1002/acm2.14573. Epub 2024 Nov 29.

  PMID: 39611734 BACKGROUND

• Baba AY, Ahmad A, Baba OY, Shahid M. Assessing Axis-specific Set-up Errors in Rectal Cancer Radiotherapy: A Prospective Cone-beam Computed Tomography-Based Study with Body Mass Index Correlation. J Med Phys. 2025 Oct-Dec;50(4):731-736. doi: 10.4103/jmp.jmp_123_25. Epub 2025 Dec 31.

  PMID: 41684502 BACKGROUND

• Mulla Z, Hashem R, AlMohamad A, Weber A, Habibullah H, Abdulmoula G, Mohiuddin MG, Ujaimi R. Effect of Body Mass Factors on Setup Displacement in Gynecologic Tumors and Subsequent Effect on PTV Margins. Adv Radiat Oncol. 2022 Oct 25;8(1):101108. doi: 10.1016/j.adro.2022.101108. eCollection 2023 Jan-Feb.

  PMID: 36483065 BACKGROUND

• Costin IC, Marcu LG. Impact of immobilization system angle, body mass index and breast size on breast radiotherapy accuracy using EPID-only setup. Heliyon. 2025 Jan 22;11(3):e42176. doi: 10.1016/j.heliyon.2025.e42176. eCollection 2025 Feb 15.

  PMID: 39959482 BACKGROUND

• Wan B, Huan FK, Ge YD, Zhao RA, Zheng YT, Liang M, Zhang YX, Zhang W, Hou L, Zhang Y, Wang HK. Influence of Site, Surgery, and BMI Binary Classification on Positioning Errors in Radiotherapy for Breast Cancer Patients: A Retrospective Study. Cancer Rep (Hoboken). 2025 Sep;8(9):e70343. doi: 10.1002/cnr2.70343.

  PMID: 40944424 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Chaoxing Liu, Dr

  Shijiazhuang People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chaoxing Liu, Dr

CONTACT

86 17603119780; 15130068099@163.com

Xiaoyan Wang, Dr

CONTACT

86 15031163260; 15031163260@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share