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Journal Article Randomized Controlled Trial Epublish 35 citations

PubMed: 31748905 DOI: 10.1007/s12032-019-1334-5

Pentoxifylline and vitamin E reduce the severity of radiotherapy-induced oral mucositis and dysphagia in head and neck cancer patients: a randomized, controlled study.

Med Oncol 37(1):8

Authors: Rana Sayed, Lamia El Wakeel, Amr S Saad, Mohamed Kelany, Manal El-Hamamsy

Affiliations

  • Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.
  • Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.
  • Clinical Oncology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

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.

MeSH

Head And Neck Neoplasms, Incidence, Vitamins, Deglutition Disorders, Hospitalization, Vitamin E, Pentoxifylline, Radiotherapy, Mucositis

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