Prevention of Oral Mucositis in Head and Neck Cancer.

NCT05853692 | Recruiting

• 1 other identifier: ID 4576
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Mucositis

Outcome Measures

Primary Outcomes (1)

• Oral Mucositis

  Yes/No

  One week after the end of Radiotherapy

Secondary Outcomes (2)

• Time of Oral Mucositis Onset

  From Day 0 to 2 months

• Severity of Oral Mucositis

  One week after the end of Radiotherapy

Study Arms (2)

Test

EXPERIMENTAL

The investigational product be administered for 63 days. Patient will use a spray based on zinc gluconate (three times a day)

Device: Zinc Gluconate

Control

ACTIVE COMPARATOR

The investigational product be administered for 63 days. Patient will use a solution based on sodium chloride and bicarbonate (5 times a day)

Device: Sodium Bicarbonate

Interventions

Zinc Gluconate DEVICE

Three times a day (spray)

Test

Sodium Bicarbonate DEVICE

Five times a day (rinse)

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of the Sacred Hearth

Roma, Italy, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Carlo Lajolo, Prof.

CONTACT

+393401004585; carlo.lajolo@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The principal investigator will be encharged of generating the allocation sequence, of enrolling the participants and of assigning the interventions to the participants. The coworkers who will evaluate the onset of OM and its severity will be blinded about the selected product.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: The study will be conducted as a single-blind randomized clinical trial (RCT). The population will be divided into two groups, receiving respectively the medical device and a solution based on Sodium Bicarbonate (5 g/L)

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: May 11, 2023
• Study Start: October 10, 2022
• Primary Completion (Estimated): October 10, 2027
• Study Completion (Estimated): June 10, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

IT (1)