NCT05214495

Omega-3 Hydrogel and Prevention of Oral Mucositis

Efficacy of Topical Oral Omega-3 Hydrogel in Prevention of Radiation-induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Controlled Clinical Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Basma Morsy · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Oral mucositis (OM) is recognized as one of the most frequent debilitating sequela encountered by head and neck cancer (HNC) patients treated by radiotherapy. The objective of the study is to assess primarily the effect of topical oral Omega-3 hydrogel in prevention of radiation-induced oral mucositis and secondarily, to test the effect of topical oral Omega-3 hydrogel on oral microbiome.

Conditions

• Mucositis Oral

Interventions

Type	Name	Description
DRUG	topical oral Omega-3 hydrogel	Topical oral Omega-3 hydrogel prepared from fish oil
DRUG	conventional preventive treatment	topical treatment including antifungal agents, anti-inflammatory mouthwash, sodium bicarbonate mouthwash. Topical anesthetics agent, topical analgesic gel as well as systemic analgesics (if needed)

Timeline

• Start date: 2022-02-09
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2022-01-28
• Last updated: 2023-01-31

Locations

1 site across 1 country: Egypt