Document Type : Original Article(s)

Authors

• Azadeh Moghaddas ¹
• Ali Rismanbaf ²
• Ali Dargahi ³
• Alireza Sadeghi ⁴
• Mehran Sharifi ⁵
• Mahboubeh Rezazadeh ⁶
• Faezeh Khozeimeh ⁷

¹ Associate Professor of Clinical Pharmacy, Department of Clinical Pharmacy, Faculty of Pharmacy, Isfahan University of Medical Sciences, Isfahan, Iran. Cancer Prevention Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.

² Department of Clinical Pharmacy and Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.

³ Department of Clinical Pharmacy and Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, I.R. Iran.

⁴ Department of Internal Medicine, Oncology and Hematology Section, School of Medicine, Isfahan University of Medical Sciences, Isfahan, I.R. Iran

⁵ Department of Internal Medicine, Oncology and Hematology Section, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. Cancer Prevention Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.

⁶ Department of Pharmaceutics, School of Pharmacy, Isfahan University of Medical Sciences, Isfahan, Iran

⁷ Department of Oral Medicine and diagnosis, Schol of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran

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 PTX mouthwash 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.

Highlights

Azadeh Moghaddas (google scholar)

Mahboubeh Rezazadeh (google scholar)

Keywords

• Oral mucositis
• Xerostomia
• Pentoxifylline
• Chemotherapy
• Mouthwash

Main Subjects

• Cancer Treatment

Please cite this article as: Moghaddas A, Rismanbaf A, Dargahi A, Sadeghi A, Sharifi M, Rezazadeh  M, Khozeimeh F. Pentoxifylline Mouthwash: A Novel Approach to Managing Chemotherapy-Induced Oral Mucositis, a Randomized, Double blind, and Placebo-controlled Clinical Trial. Middle East J Cancer. 2026; 17(3): p-p. doi: 10.30476/mejc.2026.104892.2213.