Elliott, E. A., Wright, J. R., Swann, R. S., Nguyen-Tân, F., Takita, C., Bucci, M. K., . . . Radiation Therapy Oncology Group Trial 99-13. (2006). 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. Journal of Clinical Oncology, 24, 2092–2097.
This phase 3 trial was designed to compare an emulsion containing trolamine against usual supportive care within each participating institution.
Patients were randomly assigned to one of three treatment arms: (a) prophylactic trolamine emulsion, (b) interventional trolamine emulsion, and (c) declared institutional preference.
In both trolamine arms, trolamine was applied at four-hour intervals. Patients were instructed to maintain at least four hours between trolamine and radiation therapy (RT).
Trolamine use was discontinued immediately if an allergic reaction occurred or if grade 3 dermatitis was reported in any area larger than 1.5 cm of confluent desquamation or bleeding in the treatment area.
Fifty-one institutions in various states in the United States
The study was a randomized, controlled trial.
The results demonstrate no advantage for the use of trolamine in reducing the incidence of grade 2 or higher radiodermatitis or improving patient-reported QOL.