Oral oncology · 2025
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).
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Schröter Philipp, Christ Leo Vincent, Dvornikovich Katharina, Stritzke Florian, Franke Henrik, Weusthof Katharina, Bauer Lukas, Regnery Sebastian, Deng Maximilian, Behnisch Rouven, Kolz Tracy Thecla, Herpel Christopher, Thölken Rubens, Schuler Patrick, Moratin Julius, Ristow Oliver, Rammelsberg Peter, Hoffmann Jürgen, Schwindling Franz Sebastian, Uzun-Lang Kristin, Herfarth Klaus, Adeberg Sebastian, Debus Jürgen, Held Thomas
Аннотация
BACKGROUND AND PURPOSE: 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.
MATERIALS AND METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
TRIAL REGISTRATION: NCT04454697.
MATERIALS AND METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
TRIAL REGISTRATION: NCT04454697.