A Randomized Phase II Trial of Amifostine for Head and Neck Irradiation in Lymphoma
Patients will be randomized into one of two study groups. One study group will receive
amifostine prior to daily radiation therapy and the other group will receive radiation
Amifostine will be administered 30-60 minutes prior to radiation treatment. Vital signs
will be monitored 5 minutes and 15 minutes after amifostine injection as well as immediately
following radiation treatment.
Patients will also complete a quality-of-life questionnaire on the first and last day of
radiation treatment. Follow-up questionnaires will be done at follow-up visits 1 month, 3
months, 6 months, 12 months, 18 months and 24 months after completion of radiation therapy.
Patients will be removed from the study if they develop an allergic reaction to amifostine.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the effectiveness of amifostine in reducing acute and chronic radiation-induced side effects
Andrea K. Ng, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|