Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities
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|ClinicalTrials.gov Identifier: NCT00130143|
Recruitment Status : Completed
First Posted : August 15, 2005
Last Update Posted : September 27, 2005
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Lung Cancer||Drug: Ethyol (Amifostine)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities|
|Study Start Date :||June 2003|
|Study Completion Date :||September 2004|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|