Pentoxifylline and vitamin E reduce the severity of radiotherapy-induced oral mucositis and dysphagia in head and neck cancer patients: a randomized, controlled study
The purpose of this study was to assess the impact of pentoxifylline and vitamin E on the incidence and severity of radiotherapy-induced oral mucositis and dysphagia in head and neck cancer patients. This is a prospective, randomized, controlled study. Head and neck cancer patients receiving 30–35 radiotherapy fractions with or without concurrent chemotherapy excluding those intolerant to xanthines, with any bleeding tendency were included. Sixty patients were enrolled; 30 patients received radiotherapy (control group) and 30 patients received radiotherapy with pentoxifylline and vitamin E (intervention group). The incidence, severity, onset and duration of oral mucositis and/or dysphagia were assessed. Locoregional control, quality of life, need for hospitalization, radiotherapy breaks, and adverse events were recorded and compared between groups. Pentoxifylline and vitamin E combination did not affect the incidence or the onset of oral mucositis or dysphagia. After adjusting for age, the combination reduced the incidence of severe oral mucositis (p = 0.01) and dysphagia (p = 0.012). The combination decreased the duration of oral mucositis and dysphagia by 5 weeks (p = 0.002) and 4 weeks (p = 0.003), respectively. The study drugs reduced the need for hospitalization (p = 0.002) and for radiotherapy breaks (p = 0.002) with improvement of FOIS (p = 0.014), EQ-5D index (p = 0.009) and VAS score (p = 0.012). Pentoxifylline and vitamin E decreased the occurrence of dysgeusia (p = 0.026) and fatigue (p = 0.026) without compromising locoregional control. Pentoxifylline/vitamin E combination reduced the severity and duration of acute radiotherapy-induced oral mucositis and dysphagia in head and neck cancer patients.
Trial registry ClinicalTrials.gov registration number: NCT02397486.
KeywordsHead and neck cancer Oral mucositis Dysphagia Radiation therapy Pentoxifylline Vitamin E
All authors contributed to the study conception and design. Data acquisition and analysis were performed by RS. The first draft of the manuscript was written by RS and LEWl. All authors revised and commented on previous versions of the manuscript. All authors read and approved the final manuscript.
No pharmaceutical or industrial support. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Compliance with ethical standards
Conflicts of interest
The authors declare that they have no conflict of interest.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee (Research Ethics Committee-Ain Shams University) and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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