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Completed

NCT Number: NCT00286611

Determination of Amifostine Levels During Radiation Therapy

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Iowa Department of Radiation Oncology

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood and salivary sampling of amifostine

Procedure

Sampling of blood and saliva to test for amifostine levels.

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Official study title

Serial Blood and Salivary Sampling for Validation of Quantitative Amifostine Assays

Important dates

Study start
2004
Study completion
2008
First posted
Feb 3, 2006
Registry last updated
Jun 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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