Prevention of Oral Mucositis in Head and Neck Cancer. | NCT05853692

Studies
Prevention of Oral Mucositis in Head and Neck Cancer.

NCT05853692

Sponsor

Catholic University of the Sacred Heart

Status

Recruiting

Last Update Posted

Mar 19, 2026Actual

Enrollment

130Estimated

Phase

Not Applicable

Conditions

Oral Mucositis

Interventions

Zinc Gluconate
Sodium Bicarbonate

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 10, 2022Actual

Primary Completion Date

Oct 10, 2027Estimated

Completion Date

Jun 10, 2028Estimated

First Submitted Date

Apr 7, 2023

First Submission Date that Met QC Criteria

May 8, 2023

First Posted Date

May 11, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2026

Last Update Posted Date

Mar 19, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carlo Lajolo, Prof., Catholic University of the Sacred HeartPrincipal Investigator

Lead Sponsor

Catholic University of the Sacred HeartOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Zinc Gluconate	Device	Three times a day (spray)	Test
Sodium Bicarbonate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oral Mucositis	Yes/No	One week after the end of Radiotherapy

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carlo Lajolo, Prof.	Contact	+393401004585		carlo.lajolo@unicatt.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Catholic University of the Sacred Hearth	Recruiting	Roma	Italy	00168	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013280	Stomatitis

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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)

Masking Info

Masking

Single

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.

Who Masked

Outcomes Assessor