Submitted for Publication: October 26, 2012; final revision received April 3, 2013; accepted April 17, 2013.
Published Online: June 20, 2013. doi:10.1001/jamaoto.2013.3371.
Study concept and design: Lydiatt, Schmid, Burke.
Acquisition of data: Bessette, Burke.
Analysis and interpretation of data: Lydiatt, Schmid, Sayles, Burke.
Drafting of the manuscript: Lydiatt, Schmid, Burke.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Schmid, Sayles, Burke.
Obtained funding: Lydiatt, Burke.
Administrative, technical, and material support: Lydiatt, Bessette.
Study supervision: Lydiatt.
Conflict of Interest Disclosures: Dr Lydiatt is on the head and neck panel for guideline development for the National Comprehensive Cancer Network but does not receive honorarium for participation in guideline development. Dr Burke has received grant support for his institution from Forest Research Institute and has served as a consultant to Forest and on their speakers’ bureau.
Funding/Support: The project described was supported by grant R01 MH079420 from the National Institute of Mental Health. Additional support was provided by a research support fund grant from the Nebraska Medical Center and the UNMC.
Role of the Sponsor: Forest Research Institute provided matching placebo and drug. Forest Research Institute had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Mental Health or the National Institutes of Health.
Previous Presentations: This study was presented as an oral presentation at the American Head and Neck Society and Combined Otolaryngology Spring Meetings; April 11, 2013; Orlando, Florida. Some of the data were also presented at the American Psychosocial Oncology Society Annual Meeting; February 14, 2013; Huntington Beach, California.
Additional Contributions: This manuscript is presented on behalf of the PROTECT study team: Mary Morris, BSN, James C. Lynch, PhD, Jonathan D. Beck, PharmD, Daniel D. Lydiatt, MD, Oleg N. Militsakh, MD, Alan T. Richards, MD, Russell B. Smith, MD, Aaron M. Wieland, MD, Katerina Goldman, PA-C, Jennelea R. Montanez, PA-C, Lora L. Dosen, BSN, Nikie Herrera, RN, Jane Hill, LPN, Sheryl Jungbluth, BSN, Danya O'Brien, RN, Nicole R. Strohman, BSN, Matthew Egbert, MD, Christopher J. Kratochvil, MD, Ashish Sharma, MD, Jane Theobald, MD, Steven P. Wengel, MD, Paula Danekas, PharmD, Randy Rasmussen, PharmD, Barbara L. Bayer, MSN, Micki T. Bethea, BS, Deborah S. Heimes, BS, Delores A. McArthur-Miller, MA, and Rosella Squires, BS. The data safety monitoring committee was chaired by James Anderson, PhD, with Charles A. Enke, MD, Mark H. Fleisher, MD, Donald Leopold, MD, Fredrick Petty, PhD, Toby L. Schonfeld, PhD, and Weining Zhen, MD.