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

NCT00158041 Phase 4 COMPLETED

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.

Details

Lead sponsor	Mt. Sinai Medical Center, Miami
Phase	Phase 4
Status	COMPLETED
Enrolment	452
Start date	2002-01
Completion	2005-01

Conditions

• Head and Neck Cancer
• Lung Cancer
• Lymphoma

Interventions

• Amifostine administered subcutaneously

Primary outcomes

• Incidence of nausea/vomiting
• Incidence of hypotension
• Incidence of generalized skin rash
• Incidence of injection-site skin toxicity

Countries

United States