MedTrace Logo

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

NCT06897215 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-04-09

No results posted yet for this study

Summary

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.

Conditions

  • Oral Mucositis Due to Radiation

Interventions

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.

Sponsors & Collaborators

  • Nova Scotia Health Authority

    lead OTHER

Principal Investigators

  • Murali Rajaraman · Nova Scotia Health

  • Derek Wilke · Nova Scotia Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2025-11-30
Completion
2025-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06897215 on ClinicalTrials.gov