Clinical trial NCT00286611: Determination of Amifostine Levels During Radiation Therapy
Official title: Serial Blood and Salivary Sampling for Validation of Quantitative Amifostine Assays
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Amifostine
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2006-02-03
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients receiving amifostine as a part of their standard cancer therapy.

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Department of Radiation Oncology
state: Iowa
Study officials:
affiliation: University of Iowa Hospitals & Clinics
name: John M. Buatti, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Carver College of Medicine University of Iowa
name: Douglas R. Spitz, Ph.D.
role: STUDY_DIRECTOR
References: