Head and Neck CancerPhase 4NCT00158041
Subcutaneous Amifostine Safety Study
A Phase 4 study testing Amifostine administered subcutaneously in people with Head and Neck Cancer and Lung Cancer, run by Mt. Sinai Medical Center, Miami at 1 site in United States.
Trial summary
Amifostine is a radioprotective drug which is approved by the US FDA for administration prior to each radiation treatment using the intravenous route. The study evaluated the safety of amifostine administered subcutaneously. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Lung Cancer, Lymphoma
- What is being tested?
- Amifostine administered subcutaneously
- Type of treatment
- Injection or infusion
- How many people
- 452 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Jan 2005
- Phase
- Phase 4
- 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
Who may be able to join
- Institutional criteria for administration of amifostine
- Radiation therapy
- ECOG PS of at least 2
- No distant mets
- Granulocyte count greater than 2000
- Platelet count greater than 100,000
- Creatinine less than 2.0
Who cannot join
- Allergy to amifostine
- Life expectancy less than 6 mos
- Investigational drug within last 4 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Mt. Sinai Medical Center
Miami Beach, Florida, 33140
About this study
Official title: Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities
Amifostine is a radioprotective drug which is approved by the US FDA for administration prior to each radiation treatment using the intravenous route. The study evaluated the safety of amifostine administered subcutaneously. The four targeted toxicities were nausea/vomiting, hypotension, generalized skin rash, and injection-site skin reactions.
- Conditions
- Head and Neck Cancer, Lung Cancer, Lymphoma
- Being tested
- Amifostine administered subcutaneously
- Keywords
- Amifostine, Mucositis, Nausea, Hypotension, Rash
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms, Lymphoma, Mucositis, Nausea, Hypotension, Exanthema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amifostine administered subcutaneouslyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of nausea/vomiting
Incidence of hypotension
Incidence of generalized skin rash
Incidence of injection-site skin toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2002
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 452 participants
Sponsor and investigators
- Lead sponsor
- Mt. Sinai Medical Center, Miami
- Sponsor type
- University, hospital or other
- Collaborators
- MedImmune LLC
- Investigators
- Michael A Samuels, MD, Principal investigator, Mt. Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158041
- Sponsor's protocol ID
- ETH056-01D
- Status last verified
- Sep 2005
- First submitted
- 7 Sep 2005
- Last updated
- 12 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities
- ClinicalTrials.gov ID
- NCT00158041
- Acronym / sponsor ID
- ETH056-01D
- Conditions
- Head and Neck Cancer, Lung Cancer, Lymphoma
- Keywords
- Amifostine, Mucositis, Nausea, Hypotension, Rash
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants
- Lead sponsor
- Mt. Sinai Medical Center, MiamiUniversity, hospital or other
- Collaborators
- MedImmune LLC
- Study start
- Jan 2002
- Study completion
- Jan 2005
- First posted
- 12 Sep 2005 (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.
Amifostine is a radioprotective drug which is approved by the US FDA for administration prior to each radiation treatment using the intravenous route. The study evaluated the safety of amifostine administered subcutaneously. The four targeted toxicities were nausea/vomiting, hypotension, generalized skin rash, and injection-site skin reactions.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Institutional criteria for administration of amifostine
- Radiation therapy
- ECOG PS of at least 2
- No distant mets
- Granulocyte count greater than 2000
Key exclusion criteria (3 listed)
- Allergy to amifostine
- Life expectancy less than 6 mos
- Investigational drug within last 4 weeks
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 |
|---|---|---|
| Amifostine administered subcutaneously | Drug | – |
Primary outcome
Incidence of nausea/vomiting
Incidence of hypotension
Incidence of generalized skin rash
Incidence of injection-site skin toxicity
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 12 Sep 2005.
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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.
Michael A Samuels, MD principal investigator
Mt. Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amifostine administered subcutaneously in people with Head and Neck Cancer and Lung Cancer, run by Mt. Sinai Medical Center, Miami 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 7 inclusion and 3 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 12 Sep 2005. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Incidence of nausea/vomiting. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 12 Sep 2005.