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Serial Blood and Salivary Sampling for Validation of Quantitative Amifostine Assays


N/A
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

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.

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.


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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

John M. Buatti, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Iowa Hospitals & Clinics

Authority:

United States: Institutional Review Board

Study ID:

200406002

NCT ID:

NCT00286611

Start Date:

October 2004

Completion Date:

May 2008

Related Keywords:

  • Cancer
  • Amifostine

Name

Location

University of Iowa Department of Radiation Oncology Iowa City, Iowa  52242