Omega-3 nanoemulgel in prevention of radiation-induced oral mucositis and its associated effect on microbiome: a randomized clinical trial

Basma M Morsy; Shahira El Domiaty; Mohamed A M Meheissen; Lamia A Heikal; Marwa A Meheissen; Nourhan M Aly

doi:10.1186/s12903-023-03276-5

Omega-3 nanoemulgel in prevention of radiation-induced oral mucositis and its associated effect on microbiome: a randomized clinical trial

BMC Oral Health. 2023 Aug 30;23(1):612. doi: 10.1186/s12903-023-03276-5.

Authors

Basma M Morsy¹, Shahira El Domiaty², Mohamed A M Meheissen³, Lamia A Heikal⁴, Marwa A Meheissen⁵, Nourhan M Aly⁶

Affiliations

¹ Oral Medicine, Periodontology, Oral Diagnosis, and Oral Radiology Department, Faculty of Dentistry, Alexandria University, Champolion St, 21527, Alexandria Governorate, Egypt. basma.mohamed.dent@alexu.edu.eg.
² Oral Medicine, Periodontology, Oral Diagnosis, and Oral Radiology Department, Faculty of Dentistry, Alexandria University, Champolion St, 21527, Alexandria Governorate, Egypt.
³ Clinical Oncology and Nuclear Medicine Department, Faculty of Medicine, Alexandria University, Alexandria Governorate, Egypt.
⁴ Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Alexandria Governorate, Egypt.
⁵ Medical Microbiology and Immunology Department, Faculty of Medicine, Alexandria University, Alexandria Governorate, Egypt.
⁶ Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Alexandria Governorate, Egypt.

Abstract

Background: Oral mucositis (OM) is recognized as one of the most frequent debilitating sequelae encountered by head and neck cancer (HNC) patients treated by radiotherapy. This results in severe mucosal tissue inflammation and oral ulcerations that interfere with patient's nutrition, quality of life (QoL) and survival. Omega-3 (ω-3) polyunsaturated fatty acids (PUFAs) have recently gained special interest in dealing with oral diseases owing to its anti-inflammatory, anti-oxidant and wound healing properties. Thus, this study aims to assess topical Omega-3 nanoemulgel efficacy in prevention of radiation-induced oral mucositis and regulation of oral microbial dysbiosis.

Materials and methods: Thirty-four head and neck cancer patients planned to receive radiotherapy were randomly allocated into two groups: Group I: conventional preventive treatment and Group II: topical Omega-3 nanoemulgel. Patients were evaluated at baseline, three and six weeks after treatment using the World Health Organization (WHO) grading system for oral mucositis severity, Visual Analogue Scale (VAS) for perceived pain severity, and MD-Anderson Symptom Inventory for Head and Neck cancer (MDASI-HN) for QoL. Oral swabs were collected to assess oral microbiome changes.

Results: VAS scores and WHO mucositis grades were significantly lower after six weeks of treatment with topical Omega-3 nanoemulgel when compared to the conventional treatment. The total MDASI score was significantly higher in the control group after three weeks of treatment, and the head and neck subscale differed significantly at both three and six weeks. A significant reduction in Firmicutes/Bacteroidetes ratio was observed after six weeks in the test group indicating less microbial dysbiosis.

Conclusions: Topical Omega-3 nanoemulgel demonstrated a beneficial effect in prevention of radiation-induced oral mucositis with a possibility of regulating oral microbial dysbiosis.

Keywords: Microbiome; Nanoemulgel; Omega-3; Oral mucositis; Prevention.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Dysbiosis
Humans
Microbiota*
Mucositis*
Quality of Life
Stomatitis* / etiology
Stomatitis* / prevention & control