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Patients with American Joint Committee on Cancer seventh edition stage II to stage IV squamous cell carcinoma of the head and neck who were undergoing CRT were randomized to either arm 1, which entailed high\u2010dose gabapentin (2700 mg daily) with the institutional standard of care (hydrocodone and\/or acetaminophen progressing to fentanyl as needed), or arm 2, which comprised low\u2010dose gabapentin (900\u00a0mg daily) with methadone. The primary endpoints were safety and toxicity. Secondary endpoints were pain, opioid requirement, and quality of life (QOL). Differences between the treatment arms at multiple time points were compared using a generalized linear mixed regression model with Sidak correction.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 60 patients (31 in arm 1 and 29 in arm 2) were enrolled from April 2015 to August 2017. There was no difference between the treatment arms with regard to adverse events or serious adverse events. Pain was not found to be different between the treatment arms. More patients in arm 1 did not require an opioid during treatment (42% vs 7%; <jats:italic>P<\/jats:italic>\u00a0=\u00a0.002). Patients in arm 2 experienced significantly better QOL outcomes across multiple domains, including overall health (<jats:italic>P<\/jats:italic>\u00a0=\u00a0.05), physical functioning (<jats:italic>P<\/jats:italic>\u00a0=\u00a0.04), role functioning (<jats:italic>P<\/jats:italic>\u00a0=\u00a0.01), and social functioning (<jats:italic>P<\/jats:italic>\u00a0=\u00a0.01).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>High\u2010dose prophylactic gabapentin increased the percentage of patients who required no opioid during treatment. Methadone may improve QOL compared with a regimen of short\u2010acting opioids and fentanyl. However, pain was found to significantly worsen throughout treatment regardless of treatment arm, necessitating further studies to identify a more optimal regimen.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.32676","type":"journal-article","created":{"date-parts":[[2019,12,23]],"date-time":"2019-12-23T14:41:17Z","timestamp":1577112077000},"page":"1480-1491","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":36,"title":["A single\u2010institution, randomized, pilot study evaluating the efficacy of gabapentin and methadone for patients undergoing chemoradiation for head and neck squamous cell cancer"],"prefix":"10.1002","volume":"126","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3386-8546","authenticated-orcid":false,"given":"Gregory M.","family":"Hermann","sequence":"first","affiliation":[{"name":"Department of Radiation Medicine Roswell Park Comprehensive Cancer Center Buffalo New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2089-8789","authenticated-orcid":false,"given":"Austin J.","family":"Iovoli","sequence":"additional","affiliation":[{"name":"Jacobs School of Medicine and Biomedical Sciences University at Buffalo Buffalo New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexis J.","family":"Platek","sequence":"additional","affiliation":[{"name":"Jacobs School of Medicine and Biomedical Sciences University at Buffalo Buffalo New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chong","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Biostatistics Roswell Park Comprehensive Cancer Center Buffalo New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9739-8462","authenticated-orcid":false,"given":"Austin","family":"Miller","sequence":"additional","affiliation":[{"name":"Department of Biostatistics Roswell Park Comprehensive Cancer Center Buffalo New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7229-5472","authenticated-orcid":false,"given":"Kristopher","family":"Attwood","sequence":"additional","affiliation":[{"name":"Department of Biostatistics Roswell Park Comprehensive Cancer Center Buffalo New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9513-2190","authenticated-orcid":false,"given":"Daniel J.","family":"Bourgeois","sequence":"additional","affiliation":[{"name":"Department of Radiation Medicine Roswell Park Comprehensive Cancer Center Buffalo New York"},{"name":"Radiation Oncology Mary Bird Perkins Cancer Center Baton Rouge Louisiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6703-5115","authenticated-orcid":false,"given":"Anurag K.","family":"Singh","sequence":"additional","affiliation":[{"name":"Department of Radiation Medicine Roswell Park Comprehensive Cancer Center Buffalo New York"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,12,23]]},"reference":[{"key":"e_1_2_8_2_1","volume-title":"Cancer Facts & Figures 2018","author":"American Cancer Society","year":"2018"},{"key":"e_1_2_8_3_1","unstructured":"National Comprehensive Cancer Network.Head and neck cancers. 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