The role of compounded mouthwash with or without acyclovir in managing chemotherapy-induced oral mucositis in cancer patients: a randomized controlled trial

BackgroundChemotherapy-induced oral mucositis (CIOM) is a prevalent and debilitating condition observed in cancer patients, especially in those suffering from hematologic malignancies. The present study assessed the efficacy of a compounded mouthwash, both with and without the addition of acyclovir, in the management of CIOM. Although various treatment options exist for this condition, their effectiveness remains limited, underscoring the necessity for innovative approaches to the formulation of compounded mouthwashes for improved management of CIOM.MethodsA prospective, double-blind, randomized controlled study design with 110 patients with newly diagnosed acute leukemia or who underwent hematopoietic stem cell transplantation. Participants were allocated randomly to either the acyclovir-containing mouthwash group (Arm A) or the control group without acyclovir (Arm B). The incidence, duration, and severity of mucositis were assessed via standardized scale, the World Health Organization (WHO) scale for oral mucositis.ResultsThe incidence of mucositis was significantly lower in Arm A (25.5%) compared to Arm B (45.5%), with a p-value of 0.028. Furthermore, the duration of mucositis was significantly shorter in Arm A, exhibiting a median duration of 4.5 days, in contrast to a median of 7.5 days observed in Arm B (p = 0.01). Grade 3 mucositis was absent in the acyclovir group, whereas there were five cases reported in Arm B (p = 0.045). Logistic regression analysis corroborated the protective effect of the acyclovir-containing mouthwash against the development of mucositis, yielding an odds ratio (OR) of 2.444 with a p-value of 0.03.ConclusionsThe incorporation of acyclovir into compounded mouthwash significantly reduced the incidence, severity, and duration of oral mucositis in patients undergoing chemotherapy, indicating its potential for expanded clinical application. Further large-scale studies are warranted to validate these findings and to standardize mouthwash formulations for institutional utilization.Trial registrationThis trial was approved by the Institutional Research Board (IRB) under the code R.23.05. 2176.R1. Date: 20 May 2023.