Randomized trial of standard pain control with or without gabapentin for pain related to radiation-induced mucositis in head and neck cancer

Objective: Radiation-induced mucositis (RIM) in chemoradiotherapy (CRT) for head and neck cancer (HNC) causes severe pain and worsens CRT compliance, QOL and outcome. Following retrospective reports, we conducted a randomized trial of the safety and efficacy of gabapentin for RIM-associated pain during CRT. Methods: HNC patients (pts) receiving CRT were randomized to standard pain control (SPC) with acetaminophen and opioids, or SPC plus gabapentin (SPC + G). Gabapentin was maintained at 900 mg/day for 4 weeks after CRT. Primary endpoint was maximum visual analogue scale (VAS) score during CRT, and secondary endpoints were total opioid dose, changes in QOL (EORTC QLQ-C30 and QLQ-HN 35) from baseline to 4 weeks after CRT, and adverse events. Results: Twenty-two eligible Stage III or IV pts were randomly assigned to SPC or SPC + G (n = 11 each). Twelve were treated in a locally advanced setting and 10 in a postoperative setting. Median maximum VAS scores, median total dose of opioids at maximum VAS and total dose of opioids at 4 weeks after CRT tended to be higher in the SPC + G arm (47 in SPC vs. 74 in SPC + G, p = 0.517; 215 mg vs. 745.3 mg, p = 0.880; and 1260 mg vs. 1537.5 mg, p = 0.9438, respectively), without significance. QOL analysis showed significantly worse scores in the SPC + G arm for weight gain (p = 0.005). Adverse events related to gabapentin were manageable, Conclusions: This pilot study is the first prospective randomized trial of gabapentin for RIM related pain. Gabapentin had no apparent beneficial effect. Further research into agents for RIM related pain is warranted. (C) 2016 Elsevier Ireland Ltd. All rights reserved.