Journal Article

DKFZ-2025-01746

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png 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).

Schröter, P. (First author)DKFZ* ; Christ, L. V. ; Dvornikovich, K.DKFZ* ; Stritzke, F.DKFZ* ; Franke, H.DKFZ* ; Weusthof, K.DKFZ* ; Bauer, L.DKFZ* ; Regnery, S.DKFZ* ; Deng, M.DKFZ* ; Behnisch, R. ; Kolz, T. T. ; Herpel, C. ; Thölken, R. ; Schuler, P. ; Moratin, J. ; Ristow, O. ; Rammelsberg, P. ; Hoffmann, J. ; Schwindling, F. S. ; Uzun-Lang, K.DKFZ* ; Herfarth, K.DKFZ* ; Adeberg, S. ; Debus, J.DKFZ* ; Held, T. (Last author)DKFZ*

2025
Elsevier Science Amsterdam [u.a.]

Abstract: This 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.HNC 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.Of 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.TRD 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.NCT04454697.

Keyword(s): 3D printing in radiotherapy ; Carbon Ion Radiotherapy (CIRT) ; Head and neck cancer ; Intensity-Modulated Radiotherapy (IMRT) ; Intraoral splint ; Oral toxicity ; Organ-at-Risk (OAR) sparing ; Patient-reported outcomes (PROs) ; Radiation-induced oral mucositis ; Tissue retraction device

Note: #EA:E050#LA:E050#

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Contributing Institute(s):

1. E050 KKE Strahlentherapie (E050)
2. DKTK HD zentral (HD01)

Research Program(s):

1. 315 - Bildgebung und Radioonkologie (POF4-315) (POF4-315)

Appears in the scientific report 2025

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Database coverage:
; BIOSIS Previews ; Biological Abstracts ; Clarivate Analytics Master Journal List ; Current Contents - Clinical Medicine ; Ebsco Academic Search ; Essential Science Indicators ; IF < 5 ; JCR ; SCOPUS ; Science Citation Index Expanded ; Web of Science Core Collection

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