Oral Mucositis Due to RadiationGOMSNCT06897215
A Sequential Cohort Study Exploring GELCLAIR in the Management of Oral Mucositis in Patients Receiving Radical Radiation for Head and Neck Cancer
A study testing Hyaluronic acid hydrogel in people with Oral Mucositis Due to Radiation, run by Nova Scotia Health Authority.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis Due to Radiation
- What is being tested?
- Hyaluronic acid hydrogel
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who already have parenteral feeding tubes prescribed
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
- Does Gelclair help to manage the symptoms of OM and decrease its severity?
- What do participants report as the maximum levels of pain and difficulties with swallowing?
Read more
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:
- Take the prescribed treatment for OM (Gelclair or Oncology mouthwash) once it is diagnosed, up to and including 4 weeks after radiation completes.
- Complete a weekly survey about their OM symptoms up to and including 4 weeks after radiation completes.
- 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.
Read the 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.
- Conditions
- Oral Mucositis Due to Radiation
- Being tested
- Hyaluronic acid hydrogel
- Keywords
- Oral Mucositis, Radiation toxicity, Gelclair, hyaluronic acid hydrogel
- Medical subject headings
- Stomatitis, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid hydrogelDevice
Also called Gelclair
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Hyaluronic acid hydrogel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment up to and including 4 weeks after treatment completion.
Secondary outcomes (5)
Time to Initiation of Opioid or Increase in baseline dose
Quantitative comparison between cohorts calculating (in days) the need to increase or change participant's management of OM.
Measured: From enrollment up to and including 4 weeks after radiation treatment completes.
Changes in Weight
Quantitative comparison between cohorts calculating change in weight weight (in kgs) in participants.
Measured: From enrollment up to and including 4 weeks after radiation treatment completes.
Significant treatment delays/modifications
Measured as a yes/no flag comparing totals across the cohorts
Measured: From enrollment up to and including 4 weeks after radiation treatment completes.
Requirement for feeding tube
Quantitative comparison between cohorts of total number of patients requiring a new feeding tube during the course of radiation treatment.
Measured: From enrollment up to and including 4 weeks after radiation treatment completes.
Rate of adherence to treatment protocol using Patient Reported Outcomes
Quantitative comparison between cohorts for compliance with prescribed treatment of OM measured weekly.
Measured: From enrollment up to and including 4 weeks after radiation treatment completes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Mucositis Due to RadiationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murali Rajaraman, Nova Scotia Health Authority
- Investigators
- Murali Rajaraman, Principal investigator, Nova Scotia HealthDerek Wilke, Principal investigator, Nova Scotia Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897215
- Sponsor's protocol ID
- 71716
- Acronym
- GOMS
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a single center study and IPD will not be shared with anyone outside the study personnel at this center.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sequential Cohort Study Exploring Gelclair in the Management of Oral Mucostitis (OM) in Patients Receiving Radical Radiation for Head and Neck Cancer (GOMS)
- ClinicalTrials.gov ID
- NCT06897215
- Acronym / sponsor ID
- GOMS / 71716
- Conditions
- Oral Mucositis Due to Radiation
- Keywords
- Oral Mucositis, Radiation toxicity, Gelclair, hyaluronic acid hydrogel
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does Gelclair help to manage the symptoms of OM and decrease its severity?
- 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:
- Take the prescribed treatment for OM (Gelclair or Oncology mouthwash) once it is diagnosed, up to and including 4 weeks after radiation completes.
- Complete a weekly survey about their OM symptoms up to and including 4 weeks after radiation completes.
- 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Hyaluronic acid hydrogelThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who already have parenteral feeding tubes prescribed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic acid hydrogelAlso: GelclairAssigned 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. | Device | Experimental Cohort |
Primary outcome
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.
5 secondary outcomes
Time to Initiation of Opioid or Increase in baseline dose
Time frame: 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.
Significant treatment delays/modifications
Time frame: 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.
Rate of adherence to treatment protocol using Patient Reported Outcomes
Time frame: From enrollment up to and including 4 weeks after radiation treatment completes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No. This is a single center study and IPD will not be shared with anyone outside the study personnel at this center.
Related trials for Oral Mucositis Due to Radiation
Not yet recruiting
Oral Care Program for Mouth Side Effects During Head and Neck Radiation Therapy
Head and Neck Cancer (H&N), Oral Mucositis (Ulcerative) Due to Radiation
Not yet recruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
Active, not recruitingObservational study
Multicentre Real-life Data Collection Study With CareMin650™ in the Prevention and Treatment of Oral Mucositis and Radio- and/or Chemo-induced Dermatitis
Oral Mucositis (Ulcerative), Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy
Not yet recruitingPhase 2
Aerosolized Mesenchymal Stem Cell-Derived Exosomes for the Prevention and Treatment of Radiation-Induced Oral Mucositis
Oral Mucositis (Ulcerative) Due to Radiation
RecruitingPhase 2
Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.
Oral Mucositis (Ulcerative) Due to Radiation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Murali Rajaraman principal investigator
Nova Scotia Health
Derek Wilke principal investigator
Nova Scotia Health
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid hydrogel in people with Oral Mucositis Due to Radiation, run by Nova Scotia Health Authority.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Murali Rajaraman (902-473-6405, murali.rajaraman@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.