RecruitingNot ApplicableNCT05853692

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.

Sponsor

Catholic University of the Sacred Heart

Enrollment

130 participants

Start Date

Oct 10, 2022

Study Type

INTERVENTIONAL

Conditions

Oral Mucositis

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a special gel (called Gel X) applied inside the mouth can prevent or reduce painful mouth sores (oral mucositis) that commonly develop during radiation therapy for head and neck cancers. **You may be eligible if...** - You have been diagnosed with a head or neck cancer (oral cavity, pharynx, salivary glands, or unknown primary tumor) - You are receiving radiation therapy to the head and neck area, either as the main treatment or after surgery - You are able to apply the gel yourself **You may NOT be eligible if...** - You have a known allergy to any ingredient in Gel X - You have a neurological or psychiatric condition that prevents you from applying the treatment yourself - You are currently enrolled in another clinical study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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