An interventional study of Hyaluronic acid hydrogel in Oral Mucositis Due to Radiation, sponsored by Nova Scotia Health Authority. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-09.
Sponsored by Nova Scotia Health Authority · Not applicable, Interventional, and Supportive care
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:
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:
The same data will be collected for the cohort using standard of care mouthwash for comparison.
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.
306 studies on the registry are indexed under Stomatitis; 75 are open to participants now.
This study's planned enrollment of 48 is below the median of 60 across 276 interventional studies indexed under Stomatitis.
Browse Stomatitis studies →Nova Scotia Health Authority is the lead sponsor of 264 studies on the registry; 78 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Also known as: Gelclair
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.
Time frame: From enrollment up to and including 4 weeks after treatment completion.
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: From enrollment up to and including 4 weeks after radiation treatment completes.
No study locations are listed for this record.
Plan to share: No — This is a single center study and IPD will not be shared with anyone outside the study personnel at this center.
No publications or documents are linked to this record.
Start is estimated for May 2025; primary completion for Nov 2025, 6 months later.
Of 65 non-industry interventional studies with no phase under Stomatitis, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 57. This study's planned 6 months is below that.
Counting every sponsor, half of 73 studies reached it within 14 months; a quarter within 10 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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