TY - JOUR
T1 - 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
T2 - Results of Radiation Therapy Oncology Group trial 99-13
AU - Elliott, Elizabeth A.
AU - Wright, James R.
AU - Swann, R. Suzanne
AU - Nguyen-Tân, Felix
AU - Takita, Cristiane
AU - Bucci, M Kara
AU - Garden, Adam S.
AU - Kim, Harold
AU - Hug, Eugen B.
AU - Ryu, Janice
AU - Greenberg, Michael
AU - Saxton, Jerrold P.
AU - Ang, Kie-Kian
AU - Berk, Lawrence
PY - 2006/5/1
Y1 - 2006/5/1
N2 - Purpose: 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. 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.
AB - Purpose: 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. 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.
UR - http://www.scopus.com/inward/record.url?scp=33646459968&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33646459968&partnerID=8YFLogxK
U2 - 10.1200/JCO.2005.04.9148
DO - 10.1200/JCO.2005.04.9148
M3 - Article
C2 - 16648511
AN - SCOPUS:33646459968
SN - 0732-183X
VL - 24
SP - 2092
EP - 2097
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 13
ER -