NCT07491536 Ozone Therapy With Biomimetic Oral Care for Cancer-Related Oral Mucositis
| NCT ID | NCT07491536 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pavia |
| Condition | Oral Mucositis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-03-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Oral mucositis is a frequent and often debilitating complication of radiotherapy and chemotherapy, particularly in patients treated for head and neck cancers. It is characterized by inflammation and ulceration of the oral mucosa, leading to pain, difficulty swallowing, taste disturbances, dry mouth, and impairment of daily activities. In more severe cases, oral mucositis may require modification or temporary interruption of cancer treatment. This randomized controlled clinical trial is designed to assess the clinical effectiveness of gas ozone therapy in patients with radio- and chemotherapy-induced oral mucositis. In addition, the study will evaluate whether combining ozone therapy with a structured biomimetic oral care regimen, including toothpaste and mouthwash, provides additional clinical benefit compared with ozone therapy alone. Eligible participants will be randomly assigned to one of two parallel groups. The control group will receive gas ozone therapy administered in an outpatient setting according to a standardized protocol. The experimental group will receive the same ozone therapy combined with a defined home oral care regimen. Each participant will be followed for 30 days. The primary outcome is the change in oral mucositis severity, assessed using the World Health Organization Oral Toxicity Scale. Secondary outcomes include oral pain intensity, salivary flow rates, perceived dry mouth, taste alterations, swallowing function, oral pH, overall oral health-related quality of life, and treatment tolerability. The findings of this study are expected to clarify the role of ozone-based supportive care strategies in the management of cancer therapy-related oral mucositis and to contribute to the development of standardized non-pharmacological treatment protocols.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Confirmed diagnosis of radio- and/or chemotherapy-induced oral mucositis, grade 1-3 according to the WHO Oral Toxicity Scale * Undergoing oncologic treatment for solid malignancies, particularly head and neck cancers * Clinically stable general health condition (ASA physical status I-III) * Ability to understand and comply with study procedures, including domiciliary treatment and questionnaire completion * Written informed consent provided Exclusion Criteria: * Oral mucositis grade 4 according to the WHO Oral Toxicity Scale * Active fungal or bacterial oral infections (e.g., candidiasis, ulcerative stomatitis) * Traumatic ulcers, non-oncologic mucositis, or concomitant oral mucosal diseases (e.g., lichen planus, pemphigus, graft-versus-host disease) * Ongoing head and neck radiotherapy with cumulative dose \>70 Gy or completion within 7 days prior to enrollment * Use within 14 days prior to enrollment of mouthwashes, sprays, or gels containing hyaluronic acid, ozone, aloe vera, or similar bioactive agents * Systemic or topical therapies known to interfere with salivary function or mucosal healing (e.g., anticholinergics, tricyclic antidepressants, diuretics) * Known allergy or hypersensitivity to components of the oral care products or materials used during ozone therapy * Severe or uncontrolled systemic diseases (including hepatic, renal, respiratory, or cardiac insufficiency) * Severe immunosuppression or neutropenia (neutrophils \<1,000/mm³) * Pregnancy or breastfeeding * Alcohol or substance abuse, or any condition that may compromise adherence to the protocol * Inability to attend scheduled follow-up visits through Day 30
Contact & Investigator
Andrea Scribante, Associate Professor
PRINCIPAL INVESTIGATOR
University of Pavia
Frequently Asked Questions
Who can join the NCT07491536 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oral Mucositis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07491536 currently recruiting?
Yes, NCT07491536 is actively recruiting participants. Contact the research team at andrea.scribante@unipv.it for enrollment information.
Where is the NCT07491536 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT07491536 clinical trial?
NCT07491536 is sponsored by University of Pavia. The principal investigator is Andrea Scribante, Associate Professor at University of Pavia. The trial plans to enroll 50 participants.