Clinical trial · Interventional
A Sequential Cohort Study Exploring GELCLAIR in the Management of Oral Mucositis in Patients Receiving Radical Radiation for Head and Neck Cancer
A Sequential Cohort Study Exploring Gelclair in the Management of Oral Mucostitis (OM) in Patients Receiving Radical Radiation for Head and Neck Cancer (GOMS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Mucositis Due to Radiation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyaluronic acid hydrogel | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Cohort 1
- 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 and weekly assessments during 6-7 weeks of radiation treatment up to and including 4 weeks post-radiation treatment.
- type
- EXPERIMENTAL
- label
- Experimental Cohort
- description
- 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.
- interventionNames
- Device: Hyaluronic acid hydrogel
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available