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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Catholic University of the Sacred Hearth
RECRUITING
Roma
Contact Information
Primary
Carlo Lajolo, Prof.
carlo.lajolo@unicatt.it
+393401004585
Time Frame
Start Date: 2022-10-10
Estimated Completion Date: 2026-06-10
Participants
Target number of participants: 130
Treatments
Experimental: Test
The investigational product be administered for 63 days. Patient will use a spray based on zinc gluconate (three times a day)
Active_comparator: Control
The investigational product be administered for 63 days. Patient will use a solution based on sodium chloride and bicarbonate (5 times a day)
Related Therapeutic Areas
Sponsors
Leads: Catholic University of the Sacred Heart

This content was sourced from clinicaltrials.gov