Trial reportOral oncology2025
Randomized controlled trial of semi-individualized 3D-printed tissue retraction devices vs. standard shielding splints in head and neck cancer treated with intensity-modulated and particle radiotherapy (GUARD).
Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph
Trial report in Oral oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04454697 (Geweberetraktoren für Die Strahlentherapie Von Kopf-Hals-Tumoren - Prospektive Randomisierte Phase-II-Studie), which is not on this map. Cited by 1 paper.
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1citing papers in PubMed
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Geweberetraktoren für Die Strahlentherapie Von Kopf-Hals-Tumoren - Prospektive Randomisierte Phase-II-Studie
Who cites it
1 citing paper in PubMed.
- Small device, big impact: how a simple chairside 3D-printed retractor reshapes dose and patient experience in head and neck radiotherapy.Translational cancer research · 2026Article
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Authors and funding
24 authors.
Philipp SchröterHeidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Heidelberg Ion Beam Therapy Center (HIT), Heidelberg University Hospital, Heidelberg, Germany. Electronic address: philipp.schroeter@med.uni-heidelberg.de.
Leo Vincent ChristHeidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Katharina DvornikovichHeidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Heidelberg Ion Beam Therapy Center (HIT), Heidelberg University Hospital, Heidelberg, Germany.
Florian StritzkeHeidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Heidelberg Ion Beam Therapy Center (HIT), Heidelberg University Hospital, Heidelberg, Germany.
Henrik FrankeHeidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Heidelberg Ion Beam Therapy Center (HIT), Heidelberg University Hospital, Heidelberg, Germany.
Katharina WeusthofHeidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Heidelberg Ion Beam Therapy Center (HIT), Heidelberg University Hospital, Heidelberg, Germany.
Lukas BauerHeidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Heidelberg Ion Beam Therapy Center (HIT), Heidelberg University Hospital, Heidelberg, Germany.
Sebastian RegneryHeidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Heidelberg Ion Beam Therapy Center (HIT), Heidelberg University Hospital, Heidelberg, Germany.
Maximilian DengHeidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Heidelberg Ion Beam Therapy Center (HIT), Heidelberg University Hospital, Heidelberg, Germany.
Rouven BehnischHeidelberg University, Medical Faculty Heidelberg, Institute of Medical Biometry and Informatics (IMBI), Heidelberg University Hospital, Heidelberg, Germany.
Tracy Thecla KolzHeidelberg University, Medical Faculty Heidelberg, Department of Otorhinolaryngology, Head and Neck Surgery, Heidelberg University Hospital, Heidelberg, Germany.
Christopher HerpelHeidelberg University, Medical Faculty Heidelberg, Department of Prosthetic Dentistry, Heidelberg University Hospital, Heidelberg, Germany.
Rubens ThölkenHeidelberg University, Medical Faculty Heidelberg, Department of Otorhinolaryngology, Head and Neck Surgery, Heidelberg University Hospital, Heidelberg, Germany.
Patrick SchulerHeidelberg University, Medical Faculty Heidelberg, Department of Otorhinolaryngology, Head and Neck Surgery, Heidelberg University Hospital, Heidelberg, Germany.
Julius MoratinHeidelberg University, Medical Faculty Heidelberg, Department of Oral and Cranio-Maxillofacial Surgery, Heidelberg University Hospital, Heidelberg, Germany.
Oliver RistowHeidelberg University, Medical Faculty Heidelberg, Department of Oral and Cranio-Maxillofacial Surgery, Heidelberg University Hospital, Heidelberg, Germany.
Peter RammelsbergHeidelberg University, Medical Faculty Heidelberg, Department of Prosthetic Dentistry, Heidelberg University Hospital, Heidelberg, Germany.
Jürgen HoffmannHeidelberg University, Medical Faculty Heidelberg, Department of Oral and Cranio-Maxillofacial Surgery, Heidelberg University Hospital, Heidelberg, Germany.
Franz Sebastian SchwindlingMedical University of Innsbruck, Department of Prosthetic Dentistry, Innsbruck University Hospital, Innsbruck, Austria.
Kristin Uzun-LangHeidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Heidelberg Ion Beam Therapy Center (HIT), Heidelberg University Hospital, Heidelberg, Germany.
Klaus HerfarthHeidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Heidelberg Ion Beam Therapy Center (HIT), Heidelberg University Hospital, Heidelberg, Germany.
Sebastian AdebergPhilipps-University Marburg, Faculty of Medicine, Department of Radiotherapy and Radiation Oncology, Marburg Ion-Beam Therapy Center (MIT), Marburg University Hospital, Marburg, Germany; Philipps-University Marburg, Faculty of Medicine, Department of Radiotherapy and Radiation Oncology, Marburg University Hospital, Marburg, Germany.
Jürgen DebusHeidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Heidelberg Ion Beam Therapy Center (HIT), Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Department of Radiation Oncology, Heidelberg University Hospital, and German Cancer Consortium (DKTK), Partner Site Heidelberg, German Cancer Research Center (DKFZ), Heidelberg, Germany.
Thomas HeldHeidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Radiation Oncology, Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Heidelberg Ion Beam Therapy Center (HIT), Heidelberg University Hospital, Heidelberg, Germany; Heidelberg University, Medical Faculty Heidelberg, Department of Department of Radiation Oncology, Heidelberg University Hospital, and German Cancer Consortium (DKTK), Partner Site Heidelberg, German Cancer Research Center (DKFZ), Heidelberg, Germany.
Funding
No grant is acknowledged in the PubMed record.
Abstract
background and purposeThis randomized controlled trial evaluated whether tissue-retraction devices (TRDs) lessen severe radiation-induced oral mucositis (RIOM) versus standard flexible intraoral shielding splints (IOS) in patients receiving intensity-modulated radiotherapy (IMRT), carbon-ion RT, or combined-modality RT for head-and-neck cancer (HNC). Although TRDs may spare normal tissue, randomized evidence with an active control under contemporary RT techniques remains scarce. MATERIALS AND
methodsHNC patients requiring RT at University Hospital Heidelberg (2020-2023) were randomized 1:1 to receive a semi-individualized, 3D-printed TRD or standard IOS. The primary outcome was severe RIOM (RTOG/CTCAE grade ≥3) at RT completion, assessed by video endoscopy in a predefined region adjacent/opposite to the clinical target volume. Secondary endpoints included acute and late toxicities, patient-reported outcomes (PROs), and dosimetric comparisons of organs at risk, including the tongue and palate.
resultsOf 34 randomized patients, 29 were evaluable (225 regions assessed). TRD significantly reduced the rate of RIOM grade ≥3 with 0/13 TRD vs. 9/16 IOS patients affected (p < 0.001). Grade 1-2 RIOM occurred in 7 (54 %) TRD vs. 2 (12 %) IOS. Among patients with tumors above the oral cavity, TRD significantly reduced tongue mean dose (median Dmean: 16.71 Gy [IQR: 2.41-20.71] vs. 29.26 Gy [IQR: 21.56-42.52]; p = 0.034). PROs trended toward less oral pain and swallowing difficulty with TRD.
conclusionTRD reduced severe RIOM in displaced normal tissues while improving tongue and palate dosimetry. Findings support TRD integration into clinical practice, though larger trials are needed to assess long-term patient-reported benefits and large-scale implementation.
trial registrationNCT04454697.
Indexed as
Head and Neck NeoplasmsPrinting, Three-DimensionalRadiation InjuriesRadiation ProtectionRadiotherapy, Intensity-ModulatedStomatitisAdultAgedFemaleHumansMaleMiddle AgedRadiotherapy Dosage3D printing in radiotherapyCarbon Ion Radiotherapy (CIRT)Head and neck cancerIntensity-Modulated Radiotherapy (IMRT)Intraoral splintOral toxicityOrgan-at-Risk (OAR) sparingPatient-reported outcomes (PROs)Radiation-induced oral mucositisTissue retraction device
Identifiers
PMID
40840174What OpenQuestion holds
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Registered trials
NCT04454697ClinicalTrials.gov
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.