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Ozone Therapy for Cancer Therapy-Related Oral Mucositis

NCT07638904 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 58

Last updated 2026-06-10

No results posted yet for this study

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.

Conditions

  • Oral Mucositis

Interventions

OTHER

Combined Ozone-Based Oral Care Protocol

Adult oncological patients with cancer therapy-related oral mucositis were previously managed in routine clinical practice with a combined ozone-based oral care protocol. The protocol included professional chairside ozone application to oral mucosal lesions using an ozone device with a mucosa-specific probe, followed by domiciliary use of ozonized oral care products, including ozonized hydrogel, toothpaste, and mouthwash, according to routine clinical instructions. In this retrospective observational study, no intervention will be assigned or performed for research purposes, and no change to patient management is planned.

Sponsors & Collaborators

  • University of Pavia

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2025-09-30
Completion
2025-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07638904 on ClinicalTrials.gov