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Search / Trial NCT06897215

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

Launched by NOVA SCOTIA HEALTH AUTHORITY · Mar 25, 2025

Trial Information

Current as of July 01, 2025

Not yet recruiting

Keywords

Oral Mucositis Radiation Toxicity Gelclair Hyaluronic Acid Hydrogel

ClinConnect Summary

This clinical trial is studying whether Gelclair, a lubricant gel, can help manage a painful condition called Oral Mucositis (OM) in patients with head and neck cancer who are receiving radiation therapy. The main focus is to find out if Gelclair can reduce the symptoms and severity of OM, which can make it difficult to swallow and cause significant pain. Participants in the trial will either use Gelclair or a standard mouthwash treatment for OM, and they will report their symptoms and any side effects weekly for up to four weeks after finishing their radiation treatment.

To be eligible for the trial, participants need to be diagnosed with a specific type of throat or mouth cancer and be receiving a certain amount of radiation therapy. They should also be likely to develop OM based on their treatment. The trial is open to both men and women, and participants will need to be able to read and understand English. Since the trial is not yet recruiting, there will be more information available soon for those who are interested in participating.

Gender

ALL

Eligibility criteria

  • 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

About Nova Scotia Health Authority

The Nova Scotia Health Authority (NSHA) is a leading healthcare organization dedicated to enhancing the health and well-being of individuals and communities across Nova Scotia, Canada. As the largest provider of health services in the province, NSHA is committed to advancing clinical research and innovation through rigorous clinical trials that aim to improve patient care and outcomes. With a focus on collaboration, NSHA engages healthcare professionals, researchers, and patients to address pressing health challenges and contribute to the global body of medical knowledge. By fostering a culture of evidence-based practice and continual improvement, NSHA plays a pivotal role in shaping the future of healthcare delivery in the region.

Locations

Patients applied

0 patients applied

Trial Officials

Murali Rajaraman

Principal Investigator

Nova Scotia Health

Derek Wilke

Principal Investigator

Nova Scotia Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported