Determination of Amifostine Levels During Radiation Therapy
Information source: University of Iowa
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer
Intervention: Blood and salivary sampling of amifostine (Procedure)
Phase: N/A
Status: Completed
Sponsored by: University of Iowa Official(s) and/or principal investigator(s):
John M. Buatti, M.D., Principal Investigator, Affiliation: University of Iowa Hospitals & Clinics
Douglas R. Spitz, Ph.D., Study Director, Affiliation: Carver College of Medicine University of Iowa
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.
Clinical Details
Official title: Serial Blood and Salivary Sampling for Validation of Quantitative Amifostine Assays
Study design: Other, Prospective
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University of Iowa Department of Radiation Oncology, Iowa City, Iowa 52242, United States
Additional Information
Starting date: October 2004
Ending date: May 2008
Last updated: June 9, 2008
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