Head and Neck CancerNCT00130143
Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities
A study testing Ethyol (Amifostine) in people with Head and Neck Cancer and Lung Cancer, run by The Dale & Frances Hughes Cancer Center at 1 site in United States.
Trial summary
Dry mouth occurs very often in patients who receive radiation treatment. Amifostine is a drug approved to reduce the short and long-term occurrence of dry mouth when patients receive radiation treatment for head and neck cancer. 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
- What is being tested?
- Ethyol (Amifostine)
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Sep 2004
- Phase
- Interventional
- 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
- Adult, Older adult
Who may be able to join
- Patient is eligible to receive subcutaneous amifostine under site's current practice guidelines for radioprotection.
- Eastern Cooperative Oncology Group (ECOG) performance status < 2
- Age > 18
- Patient receiving radiation therapy or combined modality therapy to treat malignancy.
- No evidence of distant metastatic disease.
- Granulocyte count (segs \& bands) > 2000/mm3 and platelet count > 100,000/mm3
Show all 10Show fewer
- Serum creatinine <2.0mg/dL
- Total bilirubin <2.0mg%, SGOT < times the upper limit of normal.
- Patients may not be entered on investigational therapeutic trials.
- Patients or guardians must be informed of and understand the investigational nature of this study and give written informed consent prior to any study procedures.
Who cannot join
- Life expectancy of <6 months
- Patients receiving only chemotherapy to treat malignancy.
- Patients who have been treated with any investigational drugs <4 weeks prior to study entry.
- General medical or psychological conditions which would not permit the patient to complete the study or sign the informed consent.
- Pregnancy; Women of childbearing potential should use an effective (for them) method of birth control throughout their participation in this study.
- Patients who are currently receiving or have received amifostine for radioprotection within the prior 6 months are excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Dale & Frances Hughes Cancer Center
East Stroudsburg, Pennsylvania, 18301
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
Dry mouth occurs very often in patients who receive radiation treatment. Amifostine is a drug approved to reduce the short and long-term occurrence of dry mouth when patients receive radiation treatment for head and neck cancer. Some studies have shown that Amifostine reduces the side effects of radiation treatment for lung cancer. The use of Amifostine is still being investigated in lung malignancies. Amifostine is found to be a protectant from radiation side effects of such normal tissues as bone marrow, skin, oral mucosal, esophagus, kidney and testes. Patients that receive radiation treatments for lung cancer may experience side effects involving the esophagus. It is hoped that patients will benefit from the protection of their esophagus and avoid delays in radiation treatment due to side effects of the radiation.
Read the detailed description
The protective capacity of thio-containing compounds against normal tissue damage from radiation have been recognized for over 40 years..
Although intravenous administration is the approved standard route, because of practical advantages there has been increasing interest in the subcutaneous administration of Ethyol, which presents multiple advantages when used for radioprotection.
Based on the data that has been presented, as well as the personal experience of this and other physicians/centers with subcutaneous administration of amifostine, the researchers are proposing an open-label study evaluating the rate and severity of toxicities associated with this route of administration. Toxicities to be assessed include nausea/vomiting, hypotension, and skin/fever reactions.
- Conditions
- Head and Neck Cancer, Lung Cancer
- Being tested
- Ethyol (Amifostine)
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethyol (Amifostine)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint: To evaluate how amifostine is given subcutaneously at each institution
To determine treatment related toxicities and safety of subcutaneous administration of amifostine for the prevention of radiation-induced toxicities
Secondary outcomes (1)
Secondary endpoints: Evaluate efficacy of amifostine in reducing radiation induced toxicities in these patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2005 (estimated)
- Study startJun 2003
- Study completionSep 2004
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- The Dale & Frances Hughes Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- MedImmune LLC
- Investigators
- Michael J. Greenberg, M.D., Principal investigator, The Dale & Frances Hughes Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130143
- Sponsor's protocol ID
- Ethyol Study #ETH156-03D
- Status last verified
- Aug 2005
- First submitted
- 12 Aug 2005
- Last updated
- 27 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 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
- NCT00130143
- Acronym / sponsor ID
- Ethyol Study #ETH156-03D
- Conditions
- Head and Neck Cancer, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- The Dale & Frances Hughes Cancer CenterUniversity, hospital or other
- Collaborators
- MedImmune LLC
- Study start
- Jun 2003
- Study completion
- Sep 2004
- First posted
- 15 Aug 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.
Dry mouth occurs very often in patients who receive radiation treatment. Amifostine is a drug approved to reduce the short and long-term occurrence of dry mouth when patients receive radiation treatment for head and neck cancer. Some studies have shown that Amifostine reduces the side effects of radiation treatment for lung cancer. The use of Amifostine is still being investigated in lung malignancies. Amifostine is found to be a protectant from radiation side effects of such normal tissues as bone marrow, skin, oral mucosal, esophagus, kidney and testes. Patients that receive radiation treatments for lung cancer may experience side effects involving the esophagus. It is hoped that patients will benefit from the protection of their esophagus and avoid delays in radiation treatment due to side effects of the radiation.
Detailed description
The protective capacity of thio-containing compounds against normal tissue damage from radiation have been recognized for over 40 years..
Although intravenous administration is the approved standard route, because of practical advantages there has been increasing interest in the subcutaneous administration of Ethyol, which presents multiple advantages when used for radioprotection.
Based on the data that has been presented, as well as the personal experience of this and other physicians/centers with subcutaneous administration of amifostine, the researchers are proposing an open-label study evaluating the rate and severity of toxicities associated with this route of administration. Toxicities to be assessed include nausea/vomiting, hypotension, and skin/fever reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient is eligible to receive subcutaneous amifostine under site's current practice guidelines for radioprotection.
- Eastern Cooperative Oncology Group (ECOG) performance status < 2
- Age > 18
- Patient receiving radiation therapy or combined modality therapy to treat malignancy.
- No evidence of distant metastatic disease.
Key exclusion criteria (6 listed)
- Life expectancy of <6 months
- Patients receiving only chemotherapy to treat malignancy.
- Patients who have been treated with any investigational drugs <4 weeks prior to study entry.
- General medical or psychological conditions which would not permit the patient to complete the study or sign the informed consent.
- Pregnancy; Women of childbearing potential should use an effective (for them) method of birth control throughout their participation in this study.
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 |
|---|---|---|
| Ethyol (Amifostine) | Drug | – |
Primary outcome
Primary endpoint: To evaluate how amifostine is given subcutaneously at each institution
To determine treatment related toxicities and safety of subcutaneous administration of amifostine for the prevention of radiation-induced toxicities
1 secondary outcome
Secondary endpoints: Evaluate efficacy of amifostine in reducing radiation induced toxicities in these patients
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 27 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 J. Greenberg, M.D. principal investigator
The Dale & Frances Hughes Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethyol (Amifostine) in people with Head and Neck Cancer and Lung Cancer, run by The Dale & Frances Hughes Cancer Center 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 10 inclusion and 6 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 27 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.
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?
Primary endpoint: To evaluate how amifostine is given subcutaneously at each institution. The study lists 2 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 27 Sep 2005.