A new clinical investigation aims to explore the efficacy of Ozone Therapy in addressing oral mucositis—a challenging side effect for patients undergoing radio- and chemotherapy for head and neck cancers. Sponsored by the University of Pavia, this innovative approach may offer a critical intervention for those suffering from painful oral conditions induced by cancer treatment.
As of October 2025, the trial has not yet begun recruitment and is currently listed as “Not yet recruiting” on ClinicalTrials.gov. Clinical teams, regulatory experts, and quality assurance professionals monitoring advancements in medical device-assisted therapies should take note, as this study could provide pivotal data. The trial combines in-office and home-based ozone therapy as a non-invasive intervention for oral mucositis.
In this article:
- What changed?
- About Ozone Therapy and the study approach
- Trial participation: Who qualifies?
- FAQ
- Conclusion
- Disclaimer
- Follow the announcement
What changed?
The University of Pavia has introduced a new clinical trial targeting oral mucositis, a common condition affecting head and neck cancer patients during treatment. This condition—often characterized by painful inflammation and ulceration of the oral mucosa—can severely impact a patient’s quality of life. Using ozone therapy, the study proposes a two-fold approach that blends in-office procedures with at-home treatments, aiming to mitigate symptoms effectively.
The listing on ClinicalTrials.gov is a key signal for regulatory and clinical professionals since it identifies potential shifts in therapeutic paradigms for managing cancer-induced mucositis. As of now, recruitment for the study has not started, but its design suggests significant implications for non-pharmaceutical interventions.
About Ozone Therapy and the study approach
Ozone therapy is gaining traction as a potential method to manage oral mucosal conditions. It involves introducing ozone—a triatomic molecule of oxygen—into affected areas. The therapy is believed to exhibit anti-inflammatory and anti-microbial properties while promoting healing.
This trial employs ozone treatment both in professional healthcare settings and through devices patients can use at home. This dual-pronged strategy seeks to maximize accessibility and therapeutic benefits.
The medical device aspect
Ozone therapy may classify as a medical device-assisted intervention under regulatory frameworks, depending on the device’s mechanism and intended use. Professionals evaluating trial outcomes should consider device safety, performance, and alignment with MDR Annex I General Safety and Performance Requirements.
View the ClinicalTrials.gov record of this study for further insights into this device-focused approach.
Trial participation: Who qualifies?
This study centers on individuals diagnosed with oral mucositis, oral stomatitis, or head and neck squamous cell carcinoma, particularly those undergoing chemotherapy or radiotherapy. Eligibility criteria will likely include verification of cancer type and treatment regimen, as well as the degree of oral mucositis severity. More detailed inclusion and exclusion criteria are anticipated closer to recruitment.
With the focus on head and neck cancer patients, clinical teams should remain updated to identify candidates who can participate and benefit from this study. Early communication with the University of Pavia could also offer guidance on referrals to potential participants.
FAQ
- What is oral mucositis?
Oral mucositis is inflammation and ulceration of the mucosal lining in the mouth, commonly seen in cancer patients undergoing chemotherapy or radiotherapy. - What makes ozone therapy unique?
Ozone therapy uses ozone molecules to deliver anti-microbial and anti-inflammatory effects, which may aid healing in damaged tissues. - Has recruitment started?
No. The trial is marked “Not yet recruiting” as of October 2025. - How can people apply?
Follow updates on ClinicalTrials.gov or contact the University of Pavia for enrollment details after recruitment begins.
Conclusion
The University of Pavia’s upcoming study on ozone therapy could pave the way for new non-drug solutions in managing oral mucositis in head and neck cancer patients. While recruitment is pending, the trial promises valuable insights into integrating medical devices in cancer care therapies. Regulatory teams, clinicians, and device researchers should prepare to monitor developments closely. Connecting early with study sponsors may ensure timely collaboration.
Disclaimer
This article is intended for informational purposes only and does not constitute legal advice. Clinical trials are subject to regulatory approval and oversight, and decisions should only be made with professional guidance.
Follow the announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07199712?term=medical+device