Ozone Therapy for Cancer Therapy-Related Oral Mucositis

NCT07638904 | Completed

• 1 other identifier: 2026-OMUC-O3
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Oral Mucositis; Cancer Therapy-Related Oral Mucositis; Ozone Therapy; Ozonized Oral Care Products; Radiotherapy; Chemotherapy; Supportive Cancer Care; World Health Organization Oral Toxicity Scale; Visual Analogue Scale; Oral Pain

Outcome Measures

Primary Outcomes (1)

• Time to Achieve Oral Mucositis Grade 1 or Lower

  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.

  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)

Secondary Outcomes (5)

• Change in Oral Pain Intensity

  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)

• Change in Oral Mucositis Severity Over Time

  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)

• Change in Oral Pain Intensity Over Time

  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)

• Oral Mucositis Severity Trends by Cancer Site

  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)

• Oral Pain Intensity Trends by Cancer Site

  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)

Study Arms (1)

Cancer Therapy-Related Oral Mucositis Cohort

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.

Other: Combined Ozone-Based Oral Care Protocol

Interventions

Combined Ozone-Based Oral Care Protocol OTHER

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.

Also known as: Chairside and Domiciliary Ozone Therapy

Cancer Therapy-Related Oral Mucositis Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult oncological patients with cancer therapy-related oral mucositis whose clinical data are already available in medical records and/or clinical documentation. Patients were previously managed in routine clinical practice for oral mucositis occurring during radiotherapy and/or chemotherapy. The study population includes patients with documented oral mucositis grade 1 or higher according to the World Health Organization Oral Toxicity Scale and available baseline and follow-up assessments of oral mucositis severity and oral pain intensity. No prospective enrollment, treatment assignment, or study-specific intervention will be performed.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 10, 2026
• Study Start: November 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: October 31, 2025
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)