Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136474
Status:
COMPLETED
Last Update Posted:
2009-11-01
First Post:
2005-08-25
Brief Title:
Amifostine for Head and Neck Irradiation in Lymphoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Randomized Phase II Trial of Amifostine for Head and Neck Irradiation in Lymphoma
Status:
COMPLETED
Status Verified Date:
2009-10
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:
The purpose of this study is determine the effects good and bad amifostine has on radiation-induced side effects of lymphoma treatment
Detailed Description:
Patients will be randomized into one of two study groups One study group will receive amifostine prior to daily radiation therapy and the other group will receive radiation therapy alone
Amifostine will be administered 30-60 minutes prior to radiation treatment Vital signs will be monitored 5 minutes and 15 minutes after amifostine injection as well as immediately following radiation treatment
Patients will also complete a quality-of-life questionnaire on the first and last day of radiation treatment Follow-up questionnaires will be done at follow-up visits 1 month 3 months 6 months 12 months 18 months and 24 months after completion of radiation therapy
Patients will be removed from the study if they develop an allergic reaction to amifostine
Amifostine will be administered 30-60 minutes prior to radiation treatment Vital signs will be monitored 5 minutes and 15 minutes after amifostine injection as well as immediately following radiation treatment
Patients will also complete a quality-of-life questionnaire on the first and last day of radiation treatment Follow-up questionnaires will be done at follow-up visits 1 month 3 months 6 months 12 months 18 months and 24 months after completion of radiation therapy
Patients will be removed from the study if they develop an allergic reaction to amifostine
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