Testing a zinc spray to prevent mouth sores in head and neck cancer radiotherapy
Compares a zinc gluconate spray with sodium bicarbonate to prevent mouth sores in adults.
Plain-language title generated from the registry record
Registry title: Prevention of Oral Mucositis in Head and Neck Cancer.
Key facts
- Where
- Roma, ItalySee the site
Where in Italy
- Catholic University of the Sacred HearthRoma, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Catholic University of the Sacred Heart
- Trial code
- NCT05853692
- Record updated
- 19 March 2026
- Original description
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.Read full original descriptionShow less
Prevention of Oral Mucositis in Subjects Undergoing Radiotherapy for Head and Neck Cancer. A Randomized Clinical Trial.
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.
Inclusion: 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.
Exclusion: Patients with any neurological and psychiatric condition having an influence on the ability to self-apply the treatment; 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; Patients participating to other clinical studies.