title: Randomized phase II trial of selenomethionine as a modulator of efficacy and toxicity of chemoradiation in squamous cell carcinoma of the head and neck.
abstract: OBJECTIVE
  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/m(2) 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/m(2) 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Michael Mix, Anurag K Singh, Shiva Dibaj, Adrienne Groman, Wainwright Jaggernauth, Youcef Rustum, Roswell Park Cancer Institute, Buffalo, NY 14263, United States.
authors.forename: Michael
authors.initials: M
authors.lastname: Mix
authors.affiliation: Michael Mix, Anurag K Singh, Shiva Dibaj, Adrienne Groman, Wainwright Jaggernauth, Youcef Rustum, Roswell Park Cancer Institute, Buffalo, NY 14263, United States.
authors.forename: Anurag K
authors.initials: AK
authors.lastname: Singh
authors.affiliation: Michael Mix, Anurag K Singh, Shiva Dibaj, Adrienne Groman, Wainwright Jaggernauth, Youcef Rustum, Roswell Park Cancer Institute, Buffalo, NY 14263, United States.
authors.forename: Michael
authors.initials: M
authors.lastname: Tills
authors.affiliation: Michael Mix, Anurag K Singh, Shiva Dibaj, Adrienne Groman, Wainwright Jaggernauth, Youcef Rustum, Roswell Park Cancer Institute, Buffalo, NY 14263, United States.
authors.forename: Shiva
authors.initials: S
authors.lastname: Dibaj
authors.affiliation: Michael Mix, Anurag K Singh, Shiva Dibaj, Adrienne Groman, Wainwright Jaggernauth, Youcef Rustum, Roswell Park Cancer Institute, Buffalo, NY 14263, United States.
authors.forename: Adrienne
authors.initials: A
authors.lastname: Groman
authors.affiliation: Michael Mix, Anurag K Singh, Shiva Dibaj, Adrienne Groman, Wainwright Jaggernauth, Youcef Rustum, Roswell Park Cancer Institute, Buffalo, NY 14263, United States.
authors.forename: Wainwright
authors.initials: W
authors.lastname: Jaggernauth
authors.affiliation: Michael Mix, Anurag K Singh, Shiva Dibaj, Adrienne Groman, Wainwright Jaggernauth, Youcef Rustum, Roswell Park Cancer Institute, Buffalo, NY 14263, United States.
authors.forename: Youcef
authors.initials: Y
authors.lastname: Rustum
authors.affiliation: Michael Mix, Anurag K Singh, Shiva Dibaj, Adrienne Groman, Wainwright Jaggernauth, Youcef Rustum, Roswell Park Cancer Institute, Buffalo, NY 14263, United States.
authors.forename: Michael B
authors.initials: MB
authors.lastname: Jameson
keywords: Chemoprotective; Chemotherapy; Radiation therapy; Radioprotector; Selenium; Squamous cell cancer