title: Phase III Trial of an emulsion containing trolamine for the prevention of radiation dermatitis in patients with advanced squamous cell carcinoma of the head and neck: results of Radiation Therapy Oncology Group Trial 99-13.
abstract: OBJECTIVE
  This multicentered phase III trial was designed to compare an emulsion containing trolamine against the usual supportive care within each participating institution for patients with head and neck cancer undergoing radiation therapy.
  
  
  METHODS
  Patients with biopsy-proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx were randomly assigned to one of the following treatments: prophylactic trolamine emulsion, interventional trolamine emulsion, or declared institutional preference. The primary outcome was the reduction in grade 2 or higher skin toxicity, as per National Cancer Institute Common Toxicity Criteria version 2.0. Secondary outcomes included patient-reported quality of life (QOL).
  
  
  RESULTS
  From October 2000 to April 2002, 547 patients from 51 institutions were entered onto the trial. The average age was 59 years. Patients were predominately male (79%) and most continued to use tobacco products (52%). The rates of grade 2 or higher radiation dermatitis were 79%, 77%, and 79% in the prophylactic, interventional, and institutional preference arms of the study, respectively. No significant differences in QOL were found.
  
  
  CONCLUSIONS
  The results of this trial demonstrate no advantage for the use of trolamine in reducing the incidence of grade 2 or higher radiation dermatitis or improving patient-reported QOL. The use of 15 different local standards of care highlights the need to continue research that will result in evidence-based recommendations to reduce the burden of radiation dermatitis.
authors.affiliation: Juravinski Cancer Centre at Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada. liz.elliott@hrcc.on.ca
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Elliott
authors.forename: James R
authors.initials: JR
authors.lastname: Wright
authors.forename: R Suzanne
authors.initials: RS
authors.lastname: Swann
authors.forename: Felix
authors.initials: F
authors.lastname: Nguyen-Tân
authors.forename: Cristiane
authors.initials: C
authors.lastname: Takita
authors.forename: M Kara
authors.initials: MK
authors.lastname: Bucci
authors.forename: Adam S
authors.initials: AS
authors.lastname: Garden
authors.forename: Harold
authors.initials: H
authors.lastname: Kim
authors.forename: Eugen B
authors.initials: EB
authors.lastname: Hug
authors.forename: Janice
authors.initials: J
authors.lastname: Ryu
authors.forename: Michael
authors.initials: M
authors.lastname: Greenberg
authors.forename: Jerrold P
authors.initials: JP
authors.lastname: Saxton
authors.forename: Kian
authors.initials: K
authors.lastname: Ang
authors.forename: Lawrence
authors.initials: L
authors.lastname: Berk
mesh_terms: D002294:Carcinoma, Squamous Cell / Q000523:psychology / Q000532:radiotherapy*; D004655:Emulsions; D004983:Ethanolamines / Q000008:administration & dosage*; D005260:Female; D006258:Head and Neck Neoplasms / Q000523:psychology / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011855:Radiodermatitis / Q000517:prevention & control*; D011878:Radiotherapy / Q000009:adverse effects
chemical_list: D004655:Emulsions; D004983:Ethanolamines; C009546:triethanolamine