| Summary: | Background: This study aims to find a correlation between <i>Candida</i> spp. oral colonisation prior to radiotherapy (RT) and (i) the development of severe oral mucositis (OM) (grade 3/4) and (ii) early development of severe OM (EOM). Methods: The protocol was registered on ClinicalTrials.gov (ID: NCT04009161) and approved by the ethical committee of the ‘Fondazione Policlinico Universitario Gemelli IRCCS’ (22858/18). An oral swab was obtained before RT to assess the presence of <i>Candida</i> spp. Severe OM occurring before a dose of 40 Gy was defined as EOM. Results: No patient developed G4 OM, and only 36/152 patients (23.7%) developed G3 OM. Tumour site and lymphocytopenia were risk factors for severe OM (OR for tumour site: 1.29, 95% CI: 1–1.67, <i>p</i> = 0.05; OR for lymphocytopenia: 8.2, 95% CI: 1.2–55.8, <i>p</i> = 0.03). We found a correlation between <i>Candida</i> spp. and EOM (OR: 5.13; 95% CI: 1.23–21.4 <i>p</i> = 0.04). Patients with oral colonisation of <i>Candida</i> spp. developed severe OM at a mean dose of 38.3 Gy (range: 28–58; SD: 7.6), while negative patients did so at a mean dose of 45.6 Gy (range: 30–66; SD: 11.1). Conclusions: <i>Candida</i> spp. in the oral cavity appears to be a predictive factor of EOM.
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