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Prevention of Oral Mucositis in Head and Neck Cancer.
Sponsor: Catholic University of the Sacred Heart
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.
Official title: Prevention of Oral Mucositis in Subjects Undergoing Radiotherapy for Head and Neck Cancer. A Randomized Clinical Trial.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2022-10-10
Completion Date
2028-06-10
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
Zinc Gluconate
Three times a day (spray)
Sodium Bicarbonate
Five times a day (rinse)
Locations (1)
Catholic University of the Sacred Hearth
Roma, Italy, Italy