Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities
The protective capacity of thio-containing compounds against normal tissue damage from
radiation have been recognized for over 40 years..
Although intravenous administration is the approved standard route, because of practical
advantages there has been increasing interest in the subcutaneous administration of Ethyol,
which presents multiple advantages when used for radioprotection.
Based on the data that has been presented, as well as the personal experience of this and
other physicians/centers with subcutaneous administration of amifostine, the researchers are
proposing an open-label study evaluating the rate and severity of toxicities associated with
this route of administration. Toxicities to be assessed include nausea/vomiting,
hypotension, and skin/fever reactions.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary endpoint: To evaluate how amifostine is given subcutaneously at each institution
Michael J. Greenberg, M.D.
The Dale & Frances Hughes Cancer Center
United States: Institutional Review Board
Ethyol Study #ETH156-03D
|The Dale & Frances Hughes Cancer Center||East Stroudsburg, Pennsylvania 18301|