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Ozone Therapy for Oral Mucositis in Patients Receiving Head and Neck Cancer Radio- and Chemotherapy

NCT07199712 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-11-25

No results posted yet for this study

Summary

Oral mucositis is a frequent and painful side effect of radio- and chemotherapy, especially in patients with head and neck cancer. It can cause severe discomfort, difficulty eating and swallowing, infections, and interruptions of cancer treatment. This study evaluates the effectiveness of ozone therapy, delivered both professionally in the dental clinic and at home with ozone-based toothpaste, mouthrinse, and gel, in reducing symptoms of oral mucositis and stomatitis.

Fifty-eight adult cancer patients with oral mucositis of at least WHO grade 1 are included. Professional ozone therapy sessions are performed in-office, combined with daily home use of ozonated products. The main goal is to determine how many days are needed for lesions to heal (WHO ≤ 1). A secondary goal is to measure pain reduction using a visual analogue scale (VAS).

This research aims to provide evidence for a supportive care protocol that may improve quality of life, reduce treatment complications, and support cancer patients during therapy.

Conditions

  • Oral Mucositis
  • Oral Stomatitis
  • Head and Neck Cancer Squamous Cell Carcinoma
  • Radiotherapy Induced Mucositis
  • Chemotherapy Induced Mucositis

Interventions

OTHER

Ozone Therapy (In-Office and Home-Based Treatment)

The intervention consists of professional in-office ozone therapy delivered with the Ozono DTA device (Sweden-Martina) applied to oral mucosal lesions. The first treatment is administered at baseline and additional sessions are performed at 48 hours, day 5, day 8, day 12, and day 15, if clinically required. Alongside in-office therapy, participants perform a 15-day domiciliary regimen with ozonated oral care products, including toothpaste with 2% ozonated sunflower oil, a mouthrinse with 4% ozonated sunflower oil solution, and a topical gel with 15% ozonated sunflower oil, each used twice daily. Clinical outcomes are assessed at each visit from baseline to day 15 with the WHO oral mucositis scale and the Visual Analogue Scale for pain.

Sponsors & Collaborators

  • University of Pavia

    lead OTHER

Principal Investigators

  • Andrea Scribante, Associate Professor · University of Pavia

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2025-11-15
Completion
2025-11-20

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 NCT07199712 on ClinicalTrials.gov