Clinical Trial

Ozone Therapy for Cancer Therapy-Related Oral Mucositis

Study acronym: OMUC-O3
Completed
View on ClinicalTrials.gov →
Summary
This retrospective observational study will evaluate clinical data already available from adult cancer patients who developed cancer therapy-related oral mucositis during radiotherapy and/or chemotherapy and who were managed in routine clinical practice with combined chairside and domiciliary ozone therapy. The study will not assign participants to any treatment and will not involve any new intervention, visit, examination, or change in patient care. Data will be extracted from existing medical records and clinical documentation. The main purpose of the study is to describe the clinical course of oral mucositis and to evaluate the time needed to reach oral mucositis grade 1 or lower according to the World Health Organization Oral Toxicity Scale. The study will also assess changes in oral pain intensity, measured using a 0 to 10 Visual Analogue Scale, from baseline to follow-up visits up to 15 days. Exploratory analyses will compare clinical trends between patients with head and neck cancers and patients with cancers in other anatomical sites. The results will be interpreted as descriptive and exploratory because the study is retrospective, single-arm, and has no control group.
Trial Details
NCT Number NCT07638904
Lead Sponsor University of Pavia
Conditions Oral Mucositis
Enrollment 58 participants
Start Date 2023-11-01
Primary Completion 2025-09-30 (estimated)
Study Completion 2025-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-10