Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130143
Status:
COMPLETED
Last Update Posted:
2005-09-27
First Post:
2005-08-12
Brief Title:
Toxicities Associated With Subcutaneous Administration of Ethyol Amifostine for the Prevention of Radiation-Induced Toxicities
Sponsor:
The Dale Frances Hughes Cancer Center
Organization:
The Dale Frances Hughes Cancer Center
Study Overview
Official Title:
Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol Amifostine for the Prevention of Radiation-Induced Toxicities
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 physicianscenters 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 nauseavomiting hypotension and skinfever reactions
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 physicianscenters 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 nauseavomiting hypotension and skinfever reactions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None