Omega-3 Hydrogel and Prevention of Oral Mucositis

Phase 2

Completed

• Conditions: Mucositis Oral
• Interventions: Drug: conventional preventive treatment; Drug: topical oral Omega-3 hydrogel

• Registration Number: NCT05214495
• Lead Sponsor: Basma Morsy

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-02
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-01-28
• Study Start: 2022-02-09
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy.
2. Patients whose radiotherapy treatment planned dose is 50 Gy or above
3. Males and females with an age not less than 18 years
4. Patients receiving radiotherapy alone or receiving concomitant cisplatin (or carboplatin) with radiotherapy.

Exclusion Criteria

1. Patients under Anticoagulants such as warfarin, heparin, or aspirin.
2. Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
3. Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional preventive treatment group	conventional preventive treatment	Patients will be given conventional preventive treatment
Topical oral Omega-3 hydrogel group	topical oral Omega-3 hydrogel	Patients will be given topical oral Omega-3 hydrogel

Primary Outcome Measures

Name	Time	Method
Oral Mucositis Severity	up to 6 weeks	Radiation induced head and neck toxicity will be scored by a scale based on clinical features from Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Trial Locations

Locations (1)

Faculty of Dentistry Alexandria University; 🇪🇬 Alexandria, Egypt