Pentoxifylline and vitamin E reduce the severity of radiotherapy-induced oral mucositis and dysphagia in head and neck cancer patients: a randomized, controlled study
Sayed, Rana; El Wakeel, Lamia; Saad, Amr S; Kelany, Mohamed; El-Hamamsy, Manal;
Abstract
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.
Other data
Title | Pentoxifylline and vitamin E reduce the severity of radiotherapy-induced oral mucositis and dysphagia in head and neck cancer patients: a randomized, controlled study | Authors | Sayed, Rana ; El Wakeel, Lamia; Saad, Amr S; Kelany, Mohamed; El-Hamamsy, Manal | Affiliations | Department of Clinical Pharmacy - Pharmacy ; Department of Clinical Pharmacy - Pharmacy ; Department of Clinical Oncology and Nuclear Medicine - Medicine ; Department of Clinical Oncology and Nuclear Medicine - Medicine ; Department of Clinical Pharmacy - Pharmacy | Keywords | Dysphagia; Head and neck cancer; Oral mucositis; Pentoxifylline; Radiation therapy; Vitamin E | Issue Date | 21-Nov-2019 | Publisher | HUMANA PRESS INC | Journal | Medical oncology (Northwood, London, England) | ISSN | 1357-0560 | DOI | 10.1007/s12032-019-1334-5 | PubMed ID | 31748905 | Web of science ID | WOS:000511714600001 |
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