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| Sponsor: | University of Iowa |
|---|---|
| Information provided by: | University of Iowa |
| ClinicalTrials.gov Identifier: | NCT00286611 |
Purpose
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 | Intervention |
|---|---|
|
Cancer |
Procedure: Blood and salivary sampling of amifostine |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | Serial Blood and Salivary Sampling for Validation of Quantitative Amifostine Assays |
| Enrollment: | 13 |
| Study Start Date: | October 2004 |
| Study Completion Date: | May 2008 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Cancer patients receiving amifostine as a part of their standard cancer therapy.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Iowa | |
| University of Iowa Department of Radiation Oncology | |
| Iowa City, Iowa, United States, 52242 | |
| 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
| Responsible Party: | Department of Radiation Oncology ( John Buatti, M.D. ) |
| Study ID Numbers: | 200406002 |
| Study First Received: | January 31, 2006 |
| Last Updated: | June 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00286611 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Amifostine |
|
Radiation-Protective Agents Amifostine Physiological Effects of Drugs Protective Agents Pharmacologic Actions |