Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities
Dry mouth occurs very often in patients who receive radiation treatment. Amifostine is a drug approved to reduce the short and long-term occurrence of dry mouth when patients receive radiation treatment for head and neck cancer. Some studies have shown that Amifostine reduces the side effects of radiation treatment for lung cancer. The use of Amifostine is still being investigated in lung malignancies. Amifostine is found to be a protectant from radiation side effects of such normal tissues as bone marrow, skin, oral mucosal, esophagus, kidney and testes. Patients that receive radiation treatments for lung cancer may experience side effects involving the esophagus. It is hoped that patients will benefit from the protection of their esophagus and avoid delays in radiation treatment due to side effects of the radiation.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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.
|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|