Omega-3 Hydrogel and Prevention of Oral Mucositis

Mucositis Oral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05214495
• Other study ID #: 0290-09/2021
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 9, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: January 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mucositis
• Mucositis Oral
• Stomatitis

Intervention

Drug:
• topical oral Omega-3 hydrogel
Topical oral Omega-3 hydrogel prepared from fish oil
• 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)

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Basma Morsy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral Mucositis Severity	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	up to 6 weeks