Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities

Lung Cancer Clinical Trial

Official title: Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer

• NCT number: NCT00130143
• Study type: Interventional
• Source: The Dale & Frances Hughes Cancer Center
• Status: Completed
• Phase: N/A
• Start date: June 2003
• Completion date: September 2004