Abstract | PURPOSE: PATIENTS AND 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. CONCLUSION: 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 | Elizabeth A Elliott, James R Wright, R Suzanne Swann, Felix Nguyen-Tân, Cristiane Takita, M Kara Bucci, Adam S Garden, Harold Kim, Eugen B Hug, Janice Ryu, Michael Greenberg, Jerrold P Saxton, Kian Ang, Lawrence Berk, Radiation Therapy Oncology Group Trial 99-13 |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 24
Issue 13
Pg. 2092-7
(May 01 2006)
ISSN: 1527-7755 [Electronic] United States |
PMID | 16648511
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
|
Chemical References |
- Emulsions
- Ethanolamines
- triethanolamine
|
Topics |
- Carcinoma, Squamous Cell
(psychology, radiotherapy)
- Emulsions
- Ethanolamines
(administration & dosage)
- Female
- Head and Neck Neoplasms
(psychology, radiotherapy)
- Humans
- Male
- Middle Aged
- Quality of Life
- Radiodermatitis
(prevention & control)
- Radiotherapy
(adverse effects)
|