NCT05853692Recruiting
Prevention of Oral Mucositis in Head and Neck Cancer.
Prevention of Oral Mucositis in Subjects Undergoing Radiotherapy for Head and Neck Cancer. A Randomized Clinical Trial.
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
Oral Mucositis (OM) consists in the painful inflammation and ulceration of the mucous membranes lining the digestive tract, lasting between 7 and 98 days; and starts as an acute inflammation of oral mucosa, tongue, and pharynx after RT exposure. Gel X spray is a product based on zinc gluconate. It could be helpful to achieve the prevention of Oral Mucositis and, in case of OM manifestation, the reduction of oral pain symptoms and to accelerate the healing process of oral mucositis ulcerations. The aim of this study is to demonstrate the efficacy of the treatment with Gel X to reduce the incidence of oral mucositis, in comparison with Sodium Bicarbonate.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 7 Apr 2023
- Start date
- 10 Oct 2022
- Primary completion date
- 10 Oct 2027
- Lead sponsor
- Catholic University of the Sacred Heart
- Diseases
- Head and neck cancer
- NCT number
- NCT05853692
What you commit to
- Study type: Interventional
- Planned participants: 130
- From 10 Oct 2022 to the primary completion date, 10 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with any neurological and psychiatric condition having an influence on the ability to self-apply the treatment
Lab values
- Patients with documented contraindication to any of the components of "Gel X" (there included eccipients): water, saccharin sodium, PVP, Taurine, Zinc Gluconate, PEG-40, Hydrogenated castor oil, Pullulan, Flavors
Other
- Patients participating to other clinical studies
Who the study is looking for
- Patients with diagnosis of the following HNC: oral cavity, pharynx, unknown primary, salivary glands, undergoing local radiotherapy for curative purpose
- Patients with diagnosis of HNC: oral cavity, pharynx, unknown primary, salivary glands, undergoing local radiotherapy as an adjuvant to surgical resection
- Patients able self-apply the product.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Catholic University of the Sacred Hearth Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.