Prevention of Oral Mucositis in Head and Neck Cancer.

Oral Mucositis Clinical Trial

— OMHNC-1  

Official title:

Prevention of Oral Mucositis in Subjects Undergoing Radiotherapy for Head and Neck Cancer. A Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05853692
• Other study ID #: ID 4576
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: June 10, 2026

Study information

• Verified date: May 2023
• Source: Catholic University of the Sacred Heart
• Contact: Carlo Lajolo, Prof.
• Phone: +393401004585
• Email: carlo.lajolo[@]unicatt.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: June 10, 2026
• Est. primary completion date: October 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Device:
• Zinc Gluconate
Three times a day (spray)
• Sodium Bicarbonate
Five times a day (rinse)

Locations

Country	Name	City	State
Italy	Catholic University of the Sacred Hearth	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral Mucositis	Yes/No	One week after the end of Radiotherapy
Secondary	Time of Oral Mucositis Onset	Days	From Day 0 to 2 months
Secondary	Severity of Oral Mucositis	Difference in Oral Mucositis Grade	One week after the end of Radiotherapy