Randomized Controlled Trial
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Oncol. Oct 10, 2015; 6(5): 166-173
Published online Oct 10, 2015. doi: 10.5306/wjco.v6.i5.166
Randomized phase II trial of selenomethionine as a modulator of efficacy and toxicity of chemoradiation in squamous cell carcinoma of the head and neck
Michael Mix, Anurag K Singh, Michael Tills, Shiva Dibaj, Adrienne Groman, Wainwright Jaggernauth, Youcef Rustum, Michael B Jameson
Michael Mix, Anurag K Singh, Shiva Dibaj, Adrienne Groman, Wainwright Jaggernauth, Youcef Rustum, Roswell Park Cancer Institute, Buffalo, NY 14263, United States
Michael Tills, Michael B Jameson, Regional Cancer Centre, Waikato Hospital, Hamilton West 3204, New Zealand
Author contributions: Singh AK participated in study design, data collection, data analysis, and drafting of the manuscript; Mix M participated in data analysis, and drafting of the manuscript; Tills M participated in study design, data collection, and data analysis; Dibaj S participated in study design and performed statistical analysis; Groman A participated in study design and performed statistical analysis; Jaggernauth W participated in study design, as well as data collection and analysis; Rustum Y participated in study design and data analysis, including selenium analyes; Jameson MB participated in designing the study, data analysis, selenium analyses, and drafting the manuscript; all authors read and approved the final manuscript.
Supported by A grant from the Health Research Council of New Zealand (in part).
Institutional review board statement: The study was reviewed and approved by the institutional review boards of Roswell Park Cancer Institute (Buffalo, NY, United States) and the Northern Y Regional Ethics Committee in New Zealand.
Clinical trial registration statement: Clinical trial registration: The clinical trial is registered with ClinicalTrials.gov, using identifier NCT01682031. Details can be found at https://clinicaltrials.gov/ct2/show/NCT01682031?term=selenium+singh&rank=1.
Informed consent statement: All study participants, or their legal guardian, provided written consent prior to study enrollment.
Conflict-of-interest statement: The authors of this manuscript having no conflicts of interest to disclose.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Anurag K Singh, MD, Professor of Medicine, Radiation Medicine Residency Program Director, University at Buffalo School of Medicine, Professor of Oncology, Director of Radiation Research, Roswell Park Cancer Institute, Elm and Carlton Streets, Buffalo, NY 14263, United States. anurag.singh@roswellpark.org
Telephone: +1-716-8451180 Fax: +1-716-8457616
Received: March 16, 2015
Peer-review started: March 24, 2015
First decision: April 27, 2015
Revised: May 9, 2015
Accepted: June 1, 2015
Article in press: June 2, 2015
Published online: October 10, 2015
Processing time: 210 Days and 12.4 Hours
Abstract

AIM: To investigate whether selenomethionine (SLM) reduces mucositis incidence in patients with head and neck squamous cell cancer (HNSCC) undergoing concurrent chemoradiation (CRT).

METHODS: In this multi-institutional, randomized, double-blind phase II trial, patients with Stage III or IV HNSCC received SLM 3600 μg/m2 or placebo twice daily for 7 d prior to CRT, once daily during CRT, and daily for 3 wk following CRT. CRT consisted of 70 Gy at 2 Gy per fraction with cisplatin 100 mg/m2 IV on days 1, 22, and 43.

RESULTS: Eighteen patients were randomized, 10 received SLM, and there were no differences in baseline factors. There was no difference in mucositis or patient-reported side effects between groups. There was no difference in overall or relapse-free survival at 12 mo.

CONCLUSION: Addition of SLM to CRT for HNSCC was well-tolerated but did not lower the incidence of severe mucositis or improve quality of life or survival outcomes.

Keywords: Selenium; Chemotherapy; Radiation therapy; Squamous cell cancer; Radioprotector; Chemoprotective

Core tip: This is an international, randomized, double-blind, placebo-controlled phase II trial evaluating the addition of selenomethionine (SLM) to concurrent chemoradiation for locally advanced squamous cell carcinoma of the head and neck. The addition of SLM was well tolerated, but did not lead to a difference in the rates of mucositis, or quality of life outcomes vs placebo.