Omega-3 Hydrogel and Prevention of Oral Mucositis

NCT05214495 | Completed Phase 2

• 1 other identifier: 0290-09/2021
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Mucositis Oral

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Topical oral Omega-3 hydrogel group

EXPERIMENTAL

Patients will be given topical oral Omega-3 hydrogel

Drug: topical oral Omega-3 hydrogel

Conventional preventive treatment group

ACTIVE COMPARATOR

Patients will be given conventional preventive treatment

Drug: conventional preventive treatment

Interventions

topical oral Omega-3 hydrogel DRUG

Topical oral Omega-3 hydrogel prepared from fish oil

Topical oral Omega-3 hydrogel group

conventional preventive treatment DRUG

topical treatment including antifungal agents, anti-inflammatory mouthwash, sodium bicarbonate mouthwash. Topical anesthetics agent, topical analgesic gel as well as systemic analgesics (if needed)

Conventional preventive treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Basma Morsy: lead

Study Sites (1)

Faculty of Dentistry Alexandria University

Alexandria, Egypt

Location

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2022
• First Posted: January 28, 2022
• Study Start: February 9, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

EG (1)