Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities|
- Primary endpoint: To evaluate how amifostine is given subcutaneously at each institution
- To determine treatment related toxicities and safety of subcutaneous administration of amifostine for the prevention of radiation-induced toxicities
- Secondary endpoints: Evaluate efficacy of amifostine in reducing radiation induced toxicities in these patients
|Study Start Date:||June 2003|
|Estimated Study Completion Date:||September 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130143
|United States, Pennsylvania|
|The Dale & Frances Hughes Cancer Center|
|East Stroudsburg, Pennsylvania, United States, 18301|
|Principal Investigator:||Michael J. Greenberg, M.D.||The Dale & Frances Hughes Cancer Center|