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

NCT06897215 | Not Yet Recruiting

• 1 other identifier: 71716
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Does Gelclair help to manage the symptoms of OM and decrease its severity?
2. 2.What do participants report as the maximum levels of pain and difficulties with swallowing?
3. 3.Take the prescribed treatment for OM (Gelclair or Oncology mouthwash) once it is diagnosed, up to and including 4 weeks after radiation completes.
4. 4.Complete a weekly survey about their OM symptoms up to and including 4 weeks after radiation completes.

Conditions

Oral Mucositis Due to Radiation

Keywords

Oral Mucositis; Radiation toxicity; Gelclair; hyaluronic acid hydrogel

Outcome Measures

Primary Outcomes (1)

• Assess the effectiveness of GelClair versus SOC mouth wash in the management of symptomatic OM.

  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 Outcomes (5)

• Time to Initiation of Opioid or Increase in baseline dose

  From enrollment up to and including 4 weeks after radiation treatment completes.

• Changes in Weight

  From enrollment up to and including 4 weeks after radiation treatment completes.

• Significant treatment delays/modifications

  From enrollment up to and including 4 weeks after radiation treatment completes.

• Requirement for feeding tube

  From enrollment up to and including 4 weeks after radiation treatment completes.

• Rate of adherence to treatment protocol using Patient Reported Outcomes

  From enrollment up to and including 4 weeks after radiation treatment completes.

Study Arms (2)

Cohort 1

NO INTERVENTION

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 Cohort

EXPERIMENTAL

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

Interventions

Hyaluronic acid hydrogel DEVICE

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.

Also known as: Gelclair

Experimental Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Patients who already have parenteral feeding tubes prescribed

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

MeSH Terms

Conditions

Stomatitis; Radiation Injuries

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Wounds and Injuries

Study Officials

• Murali Rajaraman

  Nova Scotia Health

  PRINCIPAL INVESTIGATOR

• Derek Wilke

  Nova Scotia Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Murali Rajaraman

CONTACT

902-473-6405; murali.rajaraman@nshealth.ca

Susan Chisholm

CONTACT

902-266-4919; Sue.chisholm@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Model Details: 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. 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.

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 26, 2025
• Study Start: May 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share