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Determination of Amifostine Levels During Radiation Therapy

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ClinicalTrials.gov Identifier: NCT00286611
Recruitment Status : Completed
First Posted : February 3, 2006
Last Update Posted : June 10, 2008
Sponsor:
Information provided by:
University of Iowa

Study Description
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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.


Condition or disease Intervention/treatment
Cancer Procedure: Blood and salivary sampling of amifostine

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.

Study Design
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Study Type : Observational
Actual Enrollment : 13 participants
Time Perspective: Prospective
Official Title: Serial Blood and Salivary Sampling for Validation of Quantitative Amifostine Assays
Study Start Date : October 2004
Actual Study Completion Date : May 2008

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Amifostine
Those individuals enrolled who have received amifostine as part of standard care.
 Procedure: Blood and salivary sampling of amifostine
Sampling of blood and saliva to test for amifostine levels.


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer patients receiving amifostine as a part of their standard cancer therapy.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286611


Locations
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United States, Iowa
University of Iowa Department of Radiation Oncology
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
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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
More Information
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Responsible Party: John Buatti, M.D., Department of Radiation Oncology
ClinicalTrials.gov Identifier: NCT00286611    
Other Study ID Numbers: 200406002
First Posted: February 3, 2006    Key Record Dates
Last Update Posted: June 10, 2008
Last Verified: June 2008
Keywords provided by University of Iowa:
Amifostine
Additional relevant MeSH terms:
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Amifostine
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs