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Clinical Trials in Italy / NCT05853692
Recruiting Not applicable

Prevention of Oral Mucositis in Head and Neck Cancer.

NCT05853692 · tracked via the Priya Life Science Italy tracker
Sponsor
Catholic University of the Sacred Heart
Phase
Not applicable
Started
2022-10-10
Last updated
2026-03-19

Condition(s) studied

Oral Mucositis

Investigational drug(s) / intervention(s)

Zinc GluconateSodium Bicarbonate

Zinc Gluconate: Three times a day (spray)

Sodium Bicarbonate: Five times a day (rinse)

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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 with any neurological and psychiatric condition having an influence on the ability to self-apply the treatment * Patients participating to other clinical studies

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Catholic University of the Sacred Hearth Roma Italy Recruiting

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Other trials for the same condition

Ozone Therapy With Biomimetic Oral Care for Cancer-Related Oral Mucositis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05853692 on ClinicalTrials.gov ↗ ← All trials in Italy