Clinical trial · Observational
Ozone Therapy for Cancer Therapy-Related Oral Mucositis
Retrospective Evaluation of Combined Chairside and Domiciliary Ozone Therapy for the Management of Cancer Therapy-Related Oral Mucositis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined Ozone-Based Oral Care Protocol | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cancer Therapy-Related Oral Mucositis Cohort
- description
- Adult oncological patients with documented cancer therapy-related oral mucositis grade 1 or higher according to the World Health Organization Oral Toxicity Scale. Patients were previously managed in routine clinical practice with a combined ozone-based protocol including professional chairside ozone application and domiciliary ozonized oral care products. This is a retrospective observational cohort; no treatment assignment, randomization, or study-specific intervention will be performed.
- interventionNames
- Other: Combined Ozone-Based Oral Care Protocol
Primary outcomes (1)
- measure
- Time to Achieve Oral Mucositis Grade 1 or Lower
- timeFrame
- At baseline before ozone therapy (T0), immediately after the first professional ozone application (T1), 48 hours after T1 (T2), 5 days after T1 (T3), 8 days after T1 (T4), 12 days after T1 (T5), and 15 days after T1 (T6)
- description
- Time, expressed in days, required to achieve oral mucositis grade 1 or lower according to the World Health Organization Oral Toxicity Scale. The outcome will be assessed retrospectively using clinical data already available from medical records and clinical documentation. Patients who did not reach WHO grade 1 or lower by the last available follow-up will be censored at their last valid assessment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * Oncological patients undergoing radiotherapy and/or chemotherapy * Clinical diagnosis of cancer therapy-related oral mucositis grade 1 or higher according to the World Health Organization Oral Toxicity Scale * Availability of clinical documentation including World Health Organization Oral Toxicity Scale assessments and Visual Analogue Scale pain scores at baseline and at one or more follow-up timepoints * Availability of relevant demographic and clinical information required for the retrospective analysis Exclusion Criteria: * Age younger than 18 years * Absence of a documented diagnosis of cancer therapy-related oral mucositis * Incomplete or unavailable clinical documentation for the primary and/or main secondary outcome * Missing baseline World Health Organization Oral Toxicity Scale assessment * Missing baseline Visual Analogue Scale pain assessment * Any condition making the available data unsuitable for retrospective analysis
References
Publications (0)
Data not yet available