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NCT Number: NCT05214495

Omega-3 Hydrogel and Prevention of Oral Mucositis

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.

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Key information

Conditions

Mucositis Oral Mouth Diseases Stomatitis Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty of Dentistry Alexandria University

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

topical oral Omega-3 hydrogel

Drug

Topical oral Omega-3 hydrogel prepared from fish oil

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)

Primary outcomes

  1. Oral Mucositis Severity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Basma Morsy

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2022
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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