Determination of Amifostine Levels During Radiation Therapy

This study has been completed.
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00286611
First received: January 31, 2006
Last updated: June 9, 2008
Last verified: June 2008

January 31, 2006
June 9, 2008
October 2004
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Complete list of historical versions of study NCT00286611 on ClinicalTrials.gov Archive Site
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Determination of Amifostine Levels During Radiation Therapy
Serial Blood and Salivary Sampling for Validation of Quantitative Amifostine Assays

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.

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.

Observational
Time Perspective: Prospective
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Non-Probability Sample

Cancer patients receiving amifostine as a part of their standard cancer therapy.

Cancer
Procedure: Blood and salivary sampling of amifostine
Sampling of blood and saliva to test for amifostine levels.
Amifostine
Those individuals enrolled who have received amifostine as part of standard care.
Intervention: Procedure: Blood and salivary sampling of amifostine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
May 2008
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00286611
200406002
Yes
John Buatti, M.D., Department of Radiation Oncology
University of Iowa
Not Provided
Principal Investigator: John M. Buatti, M.D. University of Iowa Hospitals & Clinics
Study Director: Douglas R. Spitz, Ph.D. Carver College of Medicine University of Iowa
University of Iowa
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP