Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286611
Status:
COMPLETED
Last Update Posted:
2008-06-10
First Post:
2006-01-31
Brief Title:
Determination of Amifostine Levels During Radiation Therapy
Sponsor:
University of Iowa
Organization:
University of Iowa
Study Overview
Official Title:
Serial Blood and Salivary Sampling for Validation of Quantitative Amifostine Assays
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None