Radiation-induced mucositis (RIM) in chemoradiation (CRT) for head and neck cancer (HNC) causes severe pain and worsens CRT compliance and outcome. Following retrospective reports that gabapentin might improve RIM-associated pain during CRT, we conducted a pilot randomized trial to analyze the safety and efficacy of gabapentin in the treatment of RIM-associated pain.Methods
HNC patients receiving CRT were randomized to receive standard pain control (SPC) or SPC plus gabapentin (SPC + G). Patients in the SPC arm received acetaminophen and opioids as analgesic, while those in the SPC + G arm received gabapentin in addition to SPC. Gabapentin dose was increased from 300 to 900 mg/day in a first week of CRT and maintained at this level for 4 weeks after CRT. The prescribed RT dose was 66–70 Gy/33–35 Fr. Concurrent chemotherapy consisted of a 3-week cycle of cisplatin (80–100 mg/m2). Primary end point was maximum VAS score during CRT. Secondary end points were total dose of opioids, change in QOL (EORTC QLQ-C30 and EORTC QLQ-HN 35) from base line to 4 weeks after CRT, and adverse events.Results
From April 2010 to October 2011, 22 eligible subjects were randomly assigned to receive SPC (n = 11) or SPC + G (n = 11). All patients were stage III or IV. Twelve were treated in a locally advanced setting and 10 in a postoperative setting. No statistically significant differences were seen in median maximum VAS scores between the arms (45.5 in SPC versus 74 in SPC + G; P = 0.390). Median total dose of acetaminophen at 4 weeks did not differ (61.5 versus 79.4 g; P = 0.13), while median total dose of opioids at maximum VAS and total dose of opioids at 4 weeks did not statistically differ but appeared higher in the SPC + G arm (140 versus 837.5 mg; P = 0.338, 937.5 versus 1537.5 mg; P = 0.762). QOL analysis showed significantly worse scores in the SPC + G arm for weight gain only (P = 0.006). Adverse events related to gabapentin were manageable.Conclusions
This is the first prospective randomized trial to analyze the safety and efficacy of gabapentin for the treatment of RIM-associated pain. Allowing for the small sample size, gabapentin may have detrimental effects for RIM and further investigation is warranted.