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NCT06897215Not yet recruiting

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 · Last updated 9 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
48 (estimated)
First submitted
20 Mar 2025
Start date
1 May 2025
Primary completion date
30 Nov 2025
Lead sponsor
Nova Scotia Health Authority
NCT number
NCT06897215

What you commit to

  • Study type: Interventional
  • Planned participants: 48
  • From 1 May 2025 to the primary completion date, 30 Nov 2025
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • \- Patients who already have parenteral feeding tubes prescribed

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.