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

Primary Purpose

Oral Mucositis

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Zinc Gluconate
Sodium Bicarbonate
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Mucositis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Catholic University of the Sacred HearthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Oral Mucositis
Yes/No

Secondary Outcome Measures

Time of Oral Mucositis Onset
Days
Severity of Oral Mucositis
Difference in Oral Mucositis Grade

Full Information

First Posted
April 7, 2023
Last Updated
May 8, 2023
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT05853692
Brief Title
Prevention of Oral Mucositis in Head and Neck Cancer.
Acronym
OMHNC-1
Official Title
Prevention of Oral Mucositis in Subjects Undergoing Radiotherapy for Head and Neck Cancer. A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2022 (Actual)
Primary Completion Date
October 10, 2025 (Anticipated)
Study Completion Date
June 10, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test
Arm Type
Experimental
Arm Description
The investigational product be administered for 63 days. Patient will use a spray based on zinc gluconate (three times a day)
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The investigational product be administered for 63 days. Patient will use a solution based on sodium chloride and bicarbonate (5 times a day)
Intervention Type
Device
Intervention Name(s)
Zinc Gluconate
Intervention Description
Three times a day (spray)
Intervention Type
Device
Intervention Name(s)
Sodium Bicarbonate
Intervention Description
Five times a day (rinse)
Primary Outcome Measure Information:
Title
Oral Mucositis
Description
Yes/No
Time Frame
One week after the end of Radiotherapy
Secondary Outcome Measure Information:
Title
Time of Oral Mucositis Onset
Description
Days
Time Frame
From Day 0 to 2 months
Title
Severity of Oral Mucositis
Description
Difference in Oral Mucositis Grade
Time Frame
One week after the end of Radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlo Lajolo, Prof.
Phone
+393401004585
Email
carlo.lajolo@unicatt.it
Facility Information:
Facility Name
Catholic University of the Sacred Hearth
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo Lajolo, Prof.
Phone
+393356078354
Email
carlo.lajolo@unicatt.it

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Prevention of Oral Mucositis in Head and Neck Cancer.

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