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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

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

From the Juravinski Cancer Centre at Hamilton Health Sciences; Department of Medicine, McMaster University, Hamilton, Ontario; Notre Dame Hospital, Montréal, Quebéc, Canada; Radiation Therapy Oncology Group, Philadelphia; Dale and Frances Hughes Cancer Center, Pocono Medical Center, East Stroudsburg, PA; University of Miami, Miami, FL; University of California San Francisco Comprehensive Cancer Center, San Francisco; University of California Davis Medical Center, Davis, CA; The University of Texas M.D. Anderson Cancer Center, Houston, TX; Wayne State University, Gershenson Radiation Oncology Center, Detroit, MI; Dartmouth Hitchcock Medical Center, Lebanon, NH; Cleveland Clinic Foundation, Cleveland; and Columbus Community Clinical Oncology Program, Columbus, OH

Address reprint requests to Elizabeth A. Elliott, MRT (T), Juravinski Cancer Centre, 699 Concession St, Hamilton, L8V5C2, Ontario, Canada; e-mail: liz.elliott{at}hrcc.on.ca

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.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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