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

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05214495

Enrollment

Registered

2022-01-28

Start date

2022-02-09

Completion date

2022-09-01

Last updated

2023-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucositis Oral

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.

Interventions

DRUGtopical oral Omega-3 hydrogel

Topical oral Omega-3 hydrogel prepared from fish oil

DRUGconventional 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026