Clinical Trials Directory

Trials / Completed

CompletedNCT00286611

Determination of Amifostine Levels During Radiation Therapy

Serial Blood and Salivary Sampling for Validation of Quantitative Amifostine Assays

Status
Completed
Phase
Study type
Observational
Enrollment
13 (actual)
Sponsor
University of Iowa · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREBlood and salivary sampling of amifostineSampling of blood and saliva to test for amifostine levels.

Timeline

Start date
2004-10-01
Completion
2008-05-01
First posted
2006-02-03
Last updated
2008-06-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00286611. Inclusion in this directory is not an endorsement.