NCT00158041

Subcutaneous Amifostine Safety Study

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 452 (planned)
• Sponsor: Mt. Sinai Medical Center, Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Amifostine is a radioprotective drug which is approved by the US FDA for administration prior to each radiation treatment using the intravenous route. The study evaluated the safety of amifostine administered subcutaneously. The four targeted toxicities were nausea/vomiting, hypotension, generalized skin rash, and injection-site skin reactions.

Conditions

• Head and Neck Cancer
• Lung Cancer
• Lymphoma

Interventions

Type	Name	Description
DRUG	Amifostine administered subcutaneously

Timeline

• Start date: 2002-01-01
• Completion: 2005-01-01
• First posted: 2005-09-12
• Last updated: 2005-09-12

Locations

1 site across 1 country: United States