The Impact of Pentoxifylline and Vitamin E on The Incidence and Severity of Radiotherapy- Induced Oral Mucositis and Dysphagia in Patients with Head and Neck Cancer

Abstract

Objective: assessment of the impact of pentoxifylline and vitamin E combination on the incidence and severity of acute radiotherapy-induced oral mucositis and/or dysphagia in head and neck cancer patients. Materials and Methods: A prospective, randomized, open-label, controlled study. All head and neck cancer patients receiving 30-35 radiotherapy fractions with or without concurrent chemotherapy excluding those intolerant to xanthines, with recent hemorrhage or using anticoagulants were included. Sixty patients were enrolled; thirty patients received radiotherapy only (control group) and thirty patients received radiotherapy with oral pentoxifylline 400 mg oral tablets twice daily and vitamin E 1000 mg oral soft gelatin capsules once daily (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 all recorded and compared between groups. Results: Pentoxifylline and vitamin E neither affected the incidence nor the onset of oral mucositis or dysphagia. After adjusting for age, the combination reduced the incidence of severe oral mucositis (p-value = 0.01) and dysphagia (p-value = 0.012). The combination decreased the median duration of oral mucositis and dysphagia by 5 weeks (p-value = 0.002) and 4 weeks (p-value = 0.003), respectively. The study drugs reduced the need for hospitalization (p-value = 0.002) and for unplanned radiotherapy breaks (p-value = 0.002) with improvement of functional oral intake scale (FOIS) score (p-value = 0.014), EuroQoL- 5-dimension (EQ-5D) index (p-value = 0.009) and visual analog scale (VAS) score (p-value = 0.012). Pentoxifylline and vitamin E decreased the occurrence of dysgeusia (3.3% in intervention group vs. 26.7 % in control group, p-value = 0.026) and fatigue (0% in intervention group vs. 20% in control group, p-value = 0.026) without affecting disease locoregional control.