title: Randomized trial of standard pain control with or without gabapentin for pain related to radiation-induced mucositis in head and neck cancer.
abstract: 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 900mg/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; 215mg vs. 745.3mg, p=0.880; and 1260mg vs. 1537.5mg, 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.
authors.affiliation: Department of Medical Oncology/Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan; Department of Oral and Maxillofacial Surgery, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan.
authors.forename: Tomoko
authors.initials: T
authors.lastname: Kataoka
authors.affiliation: Department of Medical Oncology/Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan. Electronic address: nkiyota@med.kobe-u.ac.jp.
authors.forename: Naomi
authors.initials: N
authors.lastname: Kiyota
authors.affiliation: Department of Medical Oncology/Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan.
authors.forename: Takanobu
authors.initials: T
authors.lastname: Shimada
authors.affiliation: Department of Medical Oncology/Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan.
authors.forename: Yohei
authors.initials: Y
authors.lastname: Funakoshi
authors.affiliation: Department of Medical Oncology/Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan.
authors.forename: Naoko
authors.initials: N
authors.lastname: Chayahara
authors.affiliation: Department of Medical Oncology/Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan.
authors.forename: Masanori
authors.initials: M
authors.lastname: Toyoda
authors.affiliation: Department of Medical Oncology/Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Fujiwara
authors.affiliation: Department of Otolaryngology and Head and Neck Surgery, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan.
authors.forename: Ken-Ichi
authors.initials: K
authors.lastname: Nibu
authors.affiliation: Department of Oral and Maxillofacial Surgery, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan.
authors.forename: Takahide
authors.initials: T
authors.lastname: Komori
authors.affiliation: Department of Radiation Oncology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan.
authors.forename: Ryohei
authors.initials: R
authors.lastname: Sasaki
authors.affiliation: Department of Medical Oncology/Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan; Cancer Center, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Mukohara
authors.affiliation: Department of Medical Oncology/Hematology, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan; Cancer Center, Kobe University Hospital, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan.
authors.forename: Hironobu
authors.initials: H
authors.lastname: Minami
mesh_terms: D000082:Acetaminophen / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000588:Amines / Q000627:therapeutic use*; D000700:Analgesics / Q000627:therapeutic use; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects; D002945:Cisplatin / Q000627:therapeutic use; D003509:Cyclohexanecarboxylic Acids / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D000077206:Gabapentin; D006258:Head and Neck Neoplasms / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D059408:Pain Management; D011832:Radiation Injuries / Q000188:drug therapy* / Q000209:etiology; D011878:Radiotherapy / Q000009:adverse effects*; D000077195:Squamous Cell Carcinoma of Head and Neck; D013280:Stomatitis / Q000188:drug therapy* / Q000209:etiology; D005680:gamma-Aminobutyric Acid / Q000627:therapeutic use*
chemical_list: D000588:Amines; D000700:Analgesics; D000701:Analgesics, Opioid; D000970:Antineoplastic Agents; D003509:Cyclohexanecarboxylic Acids; D000082:Acetaminophen; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin; D002945:Cisplatin
keywords: Chemoradiotherapy; Gabapentin; Head and neck cancer; Radiation-induced mucositis