OMHNC-1: Prevention of Oral Mucositis in Head and Neck Cancer.

Sponsor

Catholic University of the Sacred Heart (Other)

Overall Status

Recruiting

CT.gov ID

NCT05853692

Collaborator

(none)

130

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Mucositis	Device: Zinc Gluconate Device: Sodium Bicarbonate	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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)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)

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 10, 2022

Anticipated Primary Completion Date :

Oct 10, 2025

Anticipated Study Completion Date :

Jun 10, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test The investigational product be administered for 63 days. Patient will use a spray based on zinc gluconate (three times a day)	Device: Zinc Gluconate Three times a day (spray)
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)	Device: Sodium Bicarbonate Five times a day (rinse)

Arm

Intervention/Treatment

Experimental: Test

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

Device: Zinc Gluconate

Three times a day (spray)

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)

Device: Sodium Bicarbonate

Five times a day (rinse)

Outcome Measures

Primary Outcome Measures

Oral Mucositis [One week after the end of Radiotherapy]
Yes/No

Secondary Outcome Measures

Time of Oral Mucositis Onset [From Day 0 to 2 months]
Days
Severity of Oral Mucositis [One week after the end of Radiotherapy]
Difference in Oral Mucositis Grade

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Catholic University of the Sacred Hearth	Roma		Italy	00168

Sponsors and Collaborators

Catholic University of the Sacred Heart

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Carlo Lajolo, Prof., Catholic University of the Sacred Heart

ClinicalTrials.gov Identifier:

NCT05853692

Other Study ID Numbers:

ID 4576

First Posted:

May 11, 2023

Last Update Posted:

May 11, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Head and Neck Neoplasms

Mucositis

Stomatitis

Study Results

No Results Posted as of May 11, 2023