A Sequential Cohort Study Exploring GELCLAIR in the Management of Oral Mucositis in Patients Receiving Radical Radiation for Head and Neck Cancer (GOMS)

April 7, 2025 updated by: Murali Rajaraman, Nova Scotia Health Authority

A Sequential Cohort Study Exploring Gelclair in the Management of Oral Mucostitis (OM) in Patients Receiving Radical Radiation for Head and Neck Cancer (GOMS)

The goal of this clinical trial is to learn if Gelclair lubricant gel can help manage Oral Mucositis (OM) among Oropharyngeal and Oral cavity cancer patients receiving radiation treatment. The main questions it aims to answer are:

  1. Does Gelclair help to manage the symptoms of OM and decrease its severity?
  2. What do participants report as the maximum levels of pain and difficulties with swallowing?

Researchers will compare Gelclair to the standard of care mouthwash treatment for OM (currently used for all patients with symptomatic OM) to see if Gelclair is helpful in managing oral mucositis.

For the cohort using Gelclair, participants will:

  1. Take the prescribed treatment for OM (Gelclair or Oncology mouthwash) once it is diagnosed, up to and including 4 weeks after radiation completes.
  2. Complete a weekly survey about their OM symptoms up to and including 4 weeks after radiation completes.

2. Report any problems experienced with prescribed treatment for OM (Gelclair or mouthwash).

The same data will be collected for the cohort using standard of care mouthwash for comparison.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Radiotherapy (RT) induced mucositis, including oral mucositis (OM), is the most common high-grade toxicity observed during high dose RT for Head and Neck Cancer (HNC). Prevention usually consists of adhering to oral care protocols, avoiding irritants, and avoiding mucosal hot spots in the RT plan. Once it occurs, analgesic treatments include various mixtures of pain relief mouthwashes, NSAIDS, opioids, and steroids and antifungals as indicated.

Mucoadhesive topical coating agents have been used to treat RT induced OM.

Study eligible patients will be offered participation after clinic consultation has taken place. They will be detailed provided study information and if they consent in writing, will be assigned to the standard of care cohort (16 patients) and the experimental cohort (32 patients) in a sequential format.

The first cohort of 16 patients will be evaluated for oral mucositis (OM) using CTCAE V5 criteria and Patient Reported Outcome questionnaires while undergoing management with current standard of care for symptomatic OM which includes lidocaine-based mouthwashes as initial treatment. The subsequent (experimental) cohort of 32 patients will begin treatment with Gelclair once symptomatic OM develops with the same evaluation parameters as the previous (control) cohort. Gelclair is a hyaluronic acid hydrogel that acts as a protective film in the management of OM. This product is used internationally and has been recently approved by Health Canada as a Class 2 Medical Device with an indication to manage the symptoms of OM caused by radiotherapy and chemotherapy.

After collection of baseline data (including age, sex, cancer diagnosis and staging, relevant past medical history, treatment plan, weight, nutrional status), weekly data (includes OM grading, Patient Reported Outcome for OM, weight, analgesic requirements, parenteral nutrional requirements, side effects, adherence to protocol) during radiation therapy (RT) and for 4 weeks after RT completion is recorded.

Upon study completion, analysis will be aimed at the following outcomes:

Primary Objective: Explore the effectiveness of GelClair versus SOC mouth wash in the management of symptomatic radiation-induced OM.

Secondary Objectives: Patient reported outcomes (PRO) for maximum levels reached of odynophagia and dysphagia (assessed weekly from RT start until 4 weeks after completion)

Other measurement outcomes include time to initiation of opioid (or increase in baseline dose) measured in days, weight loss, treatment delays / modifications due to OM, requirement for feeding tube, adherence to treatment protocol, cost analysis for SOC mouthwash versus GelClair based on total days use of each agent.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with primary mucosal squamous cell carcinoma of the oropharynx or oral cavity
  • Treatment plan includes at least 60Gy of daily radiotherapy, with or without concurrent chemotherapy
  • Highly likely to develop OM CTCAE v5.0, grade 2
  • Can read and understand English

Exclusion Criteria:

- Patients who already have parenteral feeding tubes prescribed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Cohort 1
The first cohort of patients (16) will be evaluated for oral mucositis (OM) development and management while undergoing current standard of care which includes lidocaine-based mouthwashes as initial treatment and weekly assessments during 6-7 weeks of radiation treatment up to and including 4 weeks post-radiation treatment.
Experimental: Experimental Cohort
The subsequent (experimental) cohort of patients (32) will begin treatment with Gelclair once significant OM develops with the same evaluation parameters as the previous (control) cohort. Gelclair be used at the onset of Grade 2 OM topically to be swished in the oral cavity and then spit 3 times a daily during treatment and until OM symptoms resolve which is usually at least 4 weeks after completion of RT.
Device: Hyaluronic acid hydrogel
Assigned to the Experimental Cohort once OM grade 2.0 presents, Gelclair is a hyaluronic acid hydrogel that acts as a protective film in the management of OM. This product is used internationally and has been recently approved by Health Canada as a Class 2 Medical Device with an indication to manage the symptoms of OM caused by radiotherapy and chemotherapy.
Other Names:
  • Gelclair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the effectiveness of GelClair versus SOC mouth wash in the management of symptomatic OM.
Time Frame: From enrollment up to and including 4 weeks after treatment completion.
The reduction of maximum Grade 2 (CTCAE V5.0) oral mucositis will be compared between the two cohorts.
From enrollment up to and including 4 weeks after treatment completion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Initiation of Opioid or Increase in baseline dose
Time Frame: From enrollment up to and including 4 weeks after radiation treatment completes.
Quantitative comparison between cohorts calculating (in days) the need to increase or change participant's management of OM.
From enrollment up to and including 4 weeks after radiation treatment completes.
Significant treatment delays/modifications
Time Frame: From enrollment up to and including 4 weeks after radiation treatment completes.
Measured as a yes/no flag comparing totals across the cohorts
From enrollment up to and including 4 weeks after radiation treatment completes.
Requirement for feeding tube
Time Frame: From enrollment up to and including 4 weeks after radiation treatment completes.
Quantitative comparison between cohorts of total number of patients requiring a new feeding tube during the course of radiation treatment.
From enrollment up to and including 4 weeks after radiation treatment completes.
Changes in Weight
Time Frame: From enrollment up to and including 4 weeks after radiation treatment completes.
Quantitative comparison between cohorts calculating change in weight weight (in kgs) in participants.
From enrollment up to and including 4 weeks after radiation treatment completes.
Rate of adherence to treatment protocol using Patient Reported Outcomes
Time Frame: From enrollment up to and including 4 weeks after radiation treatment completes.
Quantitative comparison between cohorts for compliance with prescribed treatment of OM measured weekly.
From enrollment up to and including 4 weeks after radiation treatment completes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Investigators

  • Principal Investigator: Murali Rajaraman, Nova Scotia Health
  • Principal Investigator: Derek Wilke, Nova Scotia Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 71716

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a single center study and IPD will not be shared with anyone outside the study personnel at this center.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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