Determination of Amifostine Levels During Radiation Therapy

Completed

• Conditions: Cancer
• Interventions: Procedure: Blood and salivary sampling of amifostine

• Registration Number: NCT00286611
• Lead Sponsor: University of Iowa

Brief Summary

Currently, there are no published methods for easily determining the level of amifostine in the blood or saliva. A method has been developed within the Department of Radiation Oncology by Drs. Douglas Spitz and Gurminder Sidhu, within the Spitz Lab. This method has been tested using both animal sampling and expired blood (obtained from DeGowin blood center) mixed with amifostine.

If the method proves successful, it could then be used as a tool to quantify blood and salivary amifostine levels and possibly correlate them to treatment efficacy or limiting adverse events using amifostine. A better method of treatment, either increasing the efficacy of amifostine or reducing its unwanted side effects, could then be developed.

Detailed Description

Currently, there are no published methods for easily determining the level of amifostine in the blood or saliva. A method has been developed within the Department of Radiation Oncology by Drs. Douglas Spitz and Gurminder Sidhu, within the Spitz Lab. This method has been tested using both animal sampling and expired blood (obtained from DeGowin blood center) mixed with amifostine.

If the method proves successful, it could then be used as a tool to quantify blood and salivary amifostine levels and possibly correlate them to treatment efficacy or limiting adverse events using amifostine. A better method of treatment, either increasing the efficacy of amifostine or reducing its unwanted side effects, could then be developed.

Amifostine is an FDA-approved medication that protects the lining of the mucous membranes of the head and neck when radiation treatments are given. Normally, amifostine is injected into a vein causing side effects of nausea, vomiting and low blood pressure. The amifostine can reduce radiation side effects but does not remove them completely.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2006-01-31
• Study First Submitted QC: 2006-01-31
• Study First Posted: 2006-02-03
• Study Completion: 2008-05
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-09
• Last Update Posted: 2008-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Ability to understand and willingness to sign a written informed consent document.
• Receiving radiation treatment at University of Iowa Hospitals and Clinics.
• Voluntarily elected to receive amifostine during treatment

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Amifostine	Blood and salivary sampling of amifostine	Those individuals enrolled who have received amifostine as part of standard care.

Trial Locations

Locations (1)

University of Iowa Department of Radiation Oncology; 🇺🇸 Iowa City, Iowa, United States