Pentoxifylline Mouthwash: A Novel Approach to Managing Chemotherapy-Induced Oral Mucositis, a Randomized, Double blind, and Placebo-controlled Clinical Trial

Abstract

Background: Chemotherapy-induced oral mucositis (CIOM) is a prevalent inflammatory condition among cancer patients. Pentoxifylline (PTX), a phosphodiesterase inhibitor with established anti-inflammatory properties, has shown potential in CIOM management. The present study investigated the efficacy and safety of PTXmouthwash as a therapeutic intervention. Method: A randomized, double-blind, placebo-controlled clinical trial was conducted at Omid Hospital, Isfahan, Iran. Participants diagnosed with CIOM were randomly assigned to receive either PTX mouthwash or placebo for seven days, in addition to standard care. Pain severity was measured using the numerical rating scale. Mucositis severity, xerostomia, and quality of life were assessed via the visual analogue scale and a modified oral mucositis daily questionnaire (OMDQ), respectively, at the baseline and after seven-day follow-ups. Data analysis was conducted using statistical package for the social sciences (SPSS) software, employing a per-protocol approach. P < 0.05 was considered to be statistically significant. Results: Of the participants, 33 in the intervention group and 32 in the control group completed follow-up. There were no statistically significant differences in patients’demographic and clinical characteristics between the groups at the study's outset. The PTX group demonstrated significant improvements in mucositis grade (P = 0.02), pain score (P = 0.02), xerostomia (P = 0.03), and multiple OMDQ parameters, including overall health status, drinking ability, speech, and oral discomfort in comparison with the placebo group. No significant adverse effects were reported. Conclusion: The findings suggest that PTX mouthwash may serve as a promising adjunctive therapy for reducing the severity of oral mucositis, alleviating pain, and addressing xerostomia in patients with CIOM, warranting further exploration in larger clinical trials. © Middle East Journal of Cancer.