Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459134
Status:
COMPLETED
Last Update Posted:
2021-09-28
First Post:
2007-04-09
Brief Title:
L-Arginine Supplements in Treating Women Who Are Cancer Survivors
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Randomized Study to Determine Whether ArginMax Improves the Sexual Function and Quality of Life in Female Cancer Survivors
Status:
COMPLETED
Status Verified Date:
2021-09
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 L-arginine supplements may improve the quality of life and sexual function in women who are cancer survivors
PURPOSE This randomized clinical trial is studying an L-arginine supplement to see how well it works compared with a placebo in treating women who are cancer survivors
PURPOSE This randomized clinical trial is studying an L-arginine supplement to see how well it works compared with a placebo in treating women who are cancer survivors
Detailed Description:
OBJECTIVES
Primary
Determine whether an L-arginine-based nutritional supplement ArginMax improves the quality of life and sexual function in female cancer survivors
Secondary
Compare quality of life of patients treated with ArginMax vs placebo
Compare toxicity of these regimens in these patients
Describe the sexual function symptom clusters if any in these patients
OUTLINE This is a randomized double-blind parallel-group placebo-controlled multicenter study Patients are stratified according to ECOG performance status 0 or 1 vs 2 or 3 type of malignancy pelvic vs nonpelvic and ovarian functional status yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive an oral L-arginine-based nutritional supplement ArginMax twice daily
Arm II Patients receive oral placebo twice daily In both arms treatment continues for 12 weeks in the absence of unacceptable toxicity
Sexual function quality of life and toxicity are assessed at baseline and every 4 weeks for 12 weeks
PROJECTED ACCRUAL A total of 186 patients will be accrued for this study
Primary
Determine whether an L-arginine-based nutritional supplement ArginMax improves the quality of life and sexual function in female cancer survivors
Secondary
Compare quality of life of patients treated with ArginMax vs placebo
Compare toxicity of these regimens in these patients
Describe the sexual function symptom clusters if any in these patients
OUTLINE This is a randomized double-blind parallel-group placebo-controlled multicenter study Patients are stratified according to ECOG performance status 0 or 1 vs 2 or 3 type of malignancy pelvic vs nonpelvic and ovarian functional status yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive an oral L-arginine-based nutritional supplement ArginMax twice daily
Arm II Patients receive oral placebo twice daily In both arms treatment continues for 12 weeks in the absence of unacceptable toxicity
Sexual function quality of life and toxicity are assessed at baseline and every 4 weeks for 12 weeks
PROJECTED ACCRUAL A total of 186 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| REBACCCWFU 97106 | OTHER | NCI | httpsreporternihgovquickSearchU10CA081851 |
| U10CA081851 | NIH | None | None |