The effect of melatonin mouthwash on prevention of chemotherapy-induced oral mucositis, a randomized double blinded placebo controlled clinical trial

Abstract

Introduction

Chemotherapy can induce a range of unpleasant adverse effects, with oral mucositis being one of the most common. This condition significantly impacts patients' quality of life and can disrupt their adherence to treatment protocols. Oral mucositis serves as an important limiting factor in chemotherapy, often necessitating dose reductions or treatment delays, which in turn can compromise the overall effectiveness of the therapy. This study was conducted to investigate the effect of melatonin mouthwash on the prevention of chemotherapy-induced oral mucositis.

Methods

Following the preparation of melatonin and placebo mouthwashes, a randomized, double-blinded, placebo-controlled clinical trial was conducted on patients with solid tumor malignancies who had no oral lesions and were treated with chemotherapy regimens. The patients began using the mouthwash on the first day of their corresponding chemotherapy course, continuing for six weeks with a frequency of three times daily, 4mL per application. At the end of each week, the patients were evaluated for the severity and duration of mucositis, as well as the associated pain. Quality of life was assessed at the study's start and weekly thereafter.

Results

Seventy patients were randomized into melatonin (n = 35) and placebo (n = 35) groups. The melatonin group had a lower incidence of mucositis (11.43 % versus 34.28 %), with a relative risk of 0.74 (95 % confidence interval (CI): 0.56 to 0.96). The severity of mucositis showed statistically significant differences between the melatonin and placebo groups at the end of the fifth week (P = 0.003) and the sixth week (P = 0.002). Additionally, the intensity of pain caused by mucositis demonstrated statistically significant differences at the end of the third week (P = 0.021), the fifth week (P = 0.001), and the sixth week (P = 0.001). There was also a significant difference in the overall duration of mucositis between the melatonin and placebo groups (mean difference -8.83, 95 %CI: -14.54 to -3.12). The mouthwash was well tolerated in both groups.

Conclusion

The findings of this study suggest that melatonin mouthwash is effective in preventing chemotherapy-induced mucositis. A six-week regimen of melatonin mouthwash significantly reduces the severity and duration of mucositis, as well as the associated pain intensity.