ESTRO 2025 - Abstract Book

S1084

Clinical – Head & neck

ESTRO 2025

3491

Digital Poster Zinc Gluconate Oral Spray for Preventing Oral Mucositis in Head and Neck Cancer Patients Undergoing Radiotherapy: Preliminary Results from a RCT. Silvia Longo 1 , Cosimo Rupe 2 , Francesco Scilla 2 , Francesco Ciardo 1 , Francesco Pastore 1 , mariangela massaccesi 1 , jasmine Grech 2 , maria antonietta Gambacorta 1 , Carlo Lajolo 2 1 Dipartimento Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia,, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy. 2 Head and Neck Department, Fondazione Policlinico Universitario A. Gemelli - IRCCS," School of Dentistry, Rome, Italy Purpose/Objective: Although the introduction of Intensity Modulated Radiation Therapy (IMRT) has reduced the radiation-induced tissue toxicity, oral mucositis (OM) still represents one of the most frequent adverse events. The aim of this single-blinded randomized clinical trial (RCT)was to demonstrate the efficacy of the treatment with a Zinc Gluconate oral spray (GelX spray) (Test) to reduce the incidence of OM, in comparison with Sodium Bicarbonate (Control), in patients undergoing Radiotherapy (RT) for Head and Neck Cancers (HNC). Material/Methods: The protocol was approved by the ethical committee of the Fondazione Policlinico Universitario A. Gemelli, Rome (Ref. 42925/21) and registered at ClinicalTrials.gov (ID: NCT05853692). A stratified blocked randomization sequence was created thanks to the online software https://www.randomizer.org/. The randomization was blocked for the variable “coadjuvant chemotherapy” (CT). Patients were divided into two groups, receiving respectively the Zinc Gluconate (GelX) oral spray (Test) and a solution based on Sodium Bicarbonate (5 g/L). Differences between groups for OM incidence were evaluated by means of either the ANOVA t test, or by χ2 or Fisher exact test, depending on the nature of the variables. All statistical analyses will be performed using STATA software, version 16. Results: Within this preliminary report, 43 patients were enrolled (mean age: 65.42, SD: 11.33). The sample comprised 31 men and 12 women. Twenty-four patients (55.8%) received adjuvant chemotherapy. Mean Oral cavity dose was 42.35 Gy (SD: 13.7). Twenty patients received the experimental treatment (46.5%), while 23 pertained to the control group (53.5%). Thirty-three patients (76.75%) developed OM, 7 in a severe form (16.3%). Among the control group the incidence of OM was 79%, while in the test group this incidence was slightly lower (75%). Conclusion: The Zinc Gluconate oral spray (GelX) did not show a significant reduction in the incidence of oral mucositis (OM) compared to the Sodium Bicarbonate solution in head and neck cancer patients undergoing radiotherapy. Although the test group had a slightly lower incidence (75% vs. 79%), further studies with larger samples and longer follow-up are needed to assess its true efficacy.

Keywords: toxicity, head and neck, radiotherapy