Malignant NeoplasmsBODY-SETNCT07676032
Body Composition and Setup Errors in Radiotherapy
An observational study of Malignant Neoplasms, run by Shijiazhuang People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasms
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Mar 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pathologically confirmed malignancies receiving radical or adjuvant intensity-modulated radiotherapy at Shijiazhuang People's Hospital.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Impact of Body Composition on Setup Errors in Patients Undergoing Radiotherapy With Thermoplastic Mask Immobilization: A Single-Center Prospective Cohort Study
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.
Read the 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.
- Conditions
- Malignant Neoplasms
- Keywords
- Bioelectrical Impedance Analysis, Setup Errors, Radiotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
setup errors
Six-degree-of-freedom setup errors (Tx, Ty, Tz, Rx, Ry, Rz) measured by cone-beam computed tomography (CBCT).
Measured: Through study completion, an average of 6 months.
Secondary outcomes (4)
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).
Measured: Baseline and fraction 20 (approximately 4 weeks after baseline)
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 (%).
Measured: Baseline and fraction 20 (approximately 4 weeks after baseline).
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 (°).
Measured: Baseline and fraction 20 (approximately 4 weeks after baseline)
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).
Measured: Baseline and fraction 20 (approximately 4 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Malignant NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Shijiazhuang People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaoxing Liu, Shijiazhuang People's Hospital
- Investigators
- Chaoxing Liu, Dr, Principal investigator, Shijiazhuang People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676032
- Sponsor's protocol ID
- SJZPH-RO-2026-001
- Acronym
- BODY-SET
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23303884Chan 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.
PubMed 23295957Kecojevic 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.
PubMed 24405766Polack 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.
PubMed 29736993Dai 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.
PubMed 34344394Dou 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.
PubMed 33565516Kohli 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.
PubMed 29962845Toussaint 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.
PubMed 32917784Bas 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.
PubMed 37451156Prior-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.
PubMed 38463940Chen 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.
PubMed 40660902Ruan 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.
PubMed 39611734Baba 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.
PubMed 41684502Mulla 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.
PubMed 36483065Costin 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.
PubMed 39959482
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Body Composition on Setup Errors in Patients Undergoing Radiotherapy With Thermoplastic Mask Immobilization: A Single-Center Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07676032
- Acronym / sponsor ID
- BODY-SET / SJZPH-RO-2026-001
- Conditions
- Malignant Neoplasms
- Keywords
- Bioelectrical Impedance Analysis, Setup Errors, Radiotherapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shijiazhuang People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pathologically confirmed malignancies receiving radical or adjuvant intensity-modulated radiotherapy at Shijiazhuang People's Hospital.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Background: PubMed 23303884Chan 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.
- Background: PubMed 23295957Chan 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.
- Background: PubMed 24405766Kecojevic 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.
- Background: PubMed 29736993Polack 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.
- Background: PubMed 34344394Dai 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.
- Background: PubMed 33565516Dou 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.
- Background: PubMed 29962845Kohli 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.
- Background: PubMed 32917784Toussaint 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.
- Background: PubMed 37451156Bas 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.
- Background: PubMed 38463940Prior-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.
- Background: PubMed 40660902Chen 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.
- Background: PubMed 39611734Ruan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chaoxing Liu, Dr principal investigator
Shijiazhuang People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasms, run by Shijiazhuang People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chaoxing Liu, Dr (86 17603119780, 15130068099@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
setup errors (time frame: Through study completion, an average of 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07676032, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.