CLINICAL TRIAL article
Front. Pharmacol.
Sec. Pharmacology of Anti-Cancer Drugs
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1678161
This article is part of the Research TopicAdvancement of Chemotherapy in Breast Cancer: Predictive Markers, Resistance Mechanism and Therapeutic StrategiesView all 9 articles
Assessing the efficacy and safety of pentoxifylline in preventing chemotherapy-induced peripheral neuropathy and mucositis in breast cancer patients
Provisionally accepted
- 1Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt
- 2Mansoura University Oncology Centre, Mansoura, Egypt
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Background: Pentoxifylline (PTX) has demonstrated potential in alleviating several adverse effects induced by chemotherapy in preclinical and limited clinical investigations. Nonetheless, its efficacy in mitigating the overall toxicity associated with doxorubicin, cyclophosphamide, and taxane (AC/T) regimen in breast cancer patients remains uncertain. Methodology: This study is an open labelled clinical trial in which the participants were randomly assigned to receive either PTX (400 mg three times daily) with the standard chemotherapy regimen or standard chemotherapy alone. The outcomes of the present study include the occurrence of grade 2 or higher peripheral sensory neuropathy and mucositis evaluated according to common terminology criteria for adverse events (CTCAE v5.0). Results: A total of 106 patients completed the study (PTX: 52; control: 54). The incidence of grade 2 or higher peripheral neuropathy was higher during the taxane regimen and was notably reduced in the PTX group relative to controls (75% vs. 90.7%, P=0.03), accompanied by an extended duration until grade 2 or higher neuropathy onset in the PTX arm (log-rank P<0.0001). PTX significantly decreased the occurrence of grade 2 or higher mucositis during both the AC and taxane phases (P=0.01 and P=0.04, respectively) without causing notable differences in hematological toxicities or affecting cardiac, renal, or hepatic functions. Conclusions: The co-administration of PTX with AC/T chemotherapy in breast cancer patients significantly decreases the incidence and postpones the onset of grade 2 or higher peripheral neuropathy and the incidence of mucositis without causing additional risks for the patients. The study was registered at clinicaltrials.gov (NCT06186700).
Keywords: breast cancer, Neoadjuvant chemotherapy, Pentoxifylline, Neuropathy, Mucositis
Received: 01 Aug 2025; Accepted: 29 Sep 2025.
Copyright: © 2025 Dewidar, Mansour, Hamdy, Eltantawy, Soliman and Shams. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Omar Hamdy, omarhamdy@mans.edu.eg
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