Background: Oral mucositis, one of the most common complications of 5-fluorouracil
(5-FU) treatment, leads to several problems, including pain, diarrhea and malnutrition, and reduces
the quality of life and subsequent treatments. Melatonin, a neurohormone with anti-inflammatory
and antioxidant activities, was encapsulated in niosomes and embedded in a mucoadhesive gel formulation
as a Melatonin Niosome Gel (MNG) to perform oral mucositis treatment.
Objective: This study aimed to investigate the effectiveness of MNG for the treatment of 5-FU-induced
oral mucositis in mice.
Methods: Oral mucositis was induced in ICR mice by 5-FU and randomly assigned to receive daily
applications of the topical oral MNG, a fluocinolone acetonide gel, a blank niosome gel, or no
treatment for 5 days in comparison with a normal group. Average body weights, food consumption,
and behaviors of the mice as well as microscopic histopathology, Fourier-Transform Infrared
Spectroscopy (FTIR) analysis, proinflammatory cytokine levels, and oxidative stress markers of
the tongues were monitored and collected after sacrifice.
Results: In comparison to the normal group, the average body weights of the 5-FU-MNG mice did
not deviate from that of the normal group, nor was there a significant difference in the time to sleep
or licking (p>0.05 for both parameters). In addition, the mice treated with MNG and fluocinolone
acetonide did not show significantly different histopathological, FTIR, interleukin-1β or malondialdehyde
(MDA) results in the tongues used as the oral tissue samples.
Conclusion: Topical MNG potentially inhibits inflammation and lipid oxidative stress in 5-FU-induced