Actively Recruiting
Prevention of Oral Mucositis in Head and Neck Cancer.
Led by Catholic University of the Sacred Heart · Updated on 2026-03-19
130
Participants Needed
1
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prevention of Oral Mucositis in Head and Neck Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with head and neck cancer affecting the oral cavity, pharynx, unknown primary, or salivary glands undergoing local radiotherapy for curative purposes
- Patients diagnosed with head and neck cancer in the oral cavity, pharynx, unknown primary, or salivary glands undergoing local radiotherapy as an adjuvant to surgical resection
- Patients able to self-apply the treatment product
You will not qualify if you...
- Patients with any known allergy or contraindication to ingredients in Gel X, including water, saccharin sodium, PVP, Taurine, Zinc Gluconate, PEG-40, hydrogenated castor oil, Pullulan, or flavors
- Patients with neurological or psychiatric conditions affecting their ability to self-apply treatment
- Patients currently participating in other clinical studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Catholic University of the Sacred Hearth
Roma, Italy, Italy, 00168
Actively Recruiting
Research Team
C
Carlo Lajolo, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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