CancerNCT00286611
Determination of Amifostine Levels During Radiation Therapy
An observational study of Cancer, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Blood and salivary sampling of amifostine
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to May 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients receiving amifostine as a part of their standard cancer therapy.
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Department of Radiation Oncology
Iowa City, Iowa, 52242
About this study
Official title: Serial Blood and Salivary Sampling for Validation of Quantitative Amifostine Assays
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Blood and salivary sampling of amifostine
- Keywords
- Amifostine
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and salivary sampling of amifostineProcedure or surgery
Sampling of blood and saliva to test for amifostine levels.
| Study group | Role | What they receive |
|---|---|---|
| Amifostine | Those individuals enrolled who have received amifostine as part of standard care. Receives: Procedure: Blood and salivary sampling of amifostine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2006 (estimated)
- Study startOct 2004
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Investigators
- John M. Buatti, M.D., Principal investigator, University of Iowa Hospitals & ClinicsDouglas R. Spitz, Ph.D., Study director, Carver College of Medicine University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286611
- Sponsor's protocol ID
- 200406002
- Status last verified
- Jun 2008
- First submitted
- 31 Jan 2006
- Last updated
- 10 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Blood and Salivary Sampling for Validation of Quantitative Amifostine Assays
- ClinicalTrials.gov ID
- NCT00286611
- Acronym / sponsor ID
- 200406002
- Conditions
- Cancer
- Keywords
- Amifostine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Oct 2004
- Study completion
- May 2008 (actual)
- First posted
- 3 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amifostine | – | Procedure: Blood and salivary sampling of amifostineThose individuals enrolled who have received amifostine as part of standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients receiving amifostine as a part of their standard cancer therapy.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and salivary sampling of amifostineSampling of blood and saliva to test for amifostine levels. | Procedure or surgery | Amifostine |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M. Buatti, M.D. principal investigator
University of Iowa Hospitals & Clinics
Douglas R. Spitz, Ph.D. study director
Carver College of Medicine University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2008.