Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003170
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
1999-11-01
Brief Title:
Glutamine in Preventing Acute Diarrhea in Patients With Pelvic Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase III Double-Blind Study of Glutamine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy
Status:
COMPLETED
Status Verified Date:
2016-07
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:
RATIONALE Radiation therapy uses high-energy x-rays to damage tumor cells Glutamine may be an effective treatment for acute diarrhea caused by radiation therapy It is not known if glutamine is an effective treatment for acute diarrhea caused by radiation therapy
PURPOSE Randomized double-blinded phase III trial to determine the effectiveness of glutamine in preventing acute diarrhea in patients who have pelvic cancer and who are receiving radiation therapy
PURPOSE Randomized double-blinded phase III trial to determine the effectiveness of glutamine in preventing acute diarrhea in patients who have pelvic cancer and who are receiving radiation therapy
Detailed Description:
OBJECTIVES I Determine whether glutamine is effective in reducing the acute treatment related diarrhea in patients receiving pelvic external beam radiation therapy as adjuvant or primary treatment of malignancy II Determine whether glutamine can reduce chronic treatment related enteropathy following completion of therapy III Determine whether glutamine causes any toxicity in this situation IV Provide initial reliability and validity data for a patient bowel function questionnaire
OUTLINE This is a randomized double-blind placebo controlled study Patients are stratified by history of anterior resection of the rectum yes vs no total planned cumulative dose including boost fields of external beam radiotherapy 4500-5350 cGy vs 5350-6000 cGy vs greater than 6000 cGy use of fluorouracil none vs bolus vs continuous infusion and primary site rectal cancer vs prostate cancer vs gynecological cancer vs other Beginning the first or second day of radiotherapy patients receive either oral glutamine or a placebo twice daily including the days that they do not receive radiotherapy Patients continue on treatment throughout radiotherapy and continue 2 weeks postradiotherapy or until grade 3 diarrhea occurs Patients are followed weekly for 4 weeks then at 12 months and then at 24 months after radiotherapy
OUTLINE This is a randomized double-blind placebo controlled study Patients are stratified by history of anterior resection of the rectum yes vs no total planned cumulative dose including boost fields of external beam radiotherapy 4500-5350 cGy vs 5350-6000 cGy vs greater than 6000 cGy use of fluorouracil none vs bolus vs continuous infusion and primary site rectal cancer vs prostate cancer vs gynecological cancer vs other Beginning the first or second day of radiotherapy patients receive either oral glutamine or a placebo twice daily including the days that they do not receive radiotherapy Patients continue on treatment throughout radiotherapy and continue 2 weeks postradiotherapy or until grade 3 diarrhea occurs Patients are followed weekly for 4 weeks then at 12 months and then at 24 months after radiotherapy
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-P97-0127 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065974 | REGISTRY | None | None |