Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354432
Status:
TERMINATED
Last Update Posted:
2021-09-28
First Post:
2006-07-19
Brief Title:
Soy ProteinEffexor Hormone Therapy for Prostate Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Randomized Study of Soy Protein and Effexor on Vasomotor Symptoms of Men With Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Stopped by the DSMB for lack of effect per interim stopping rule
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Soy proteinisoflavones and venlafaxine may help relieve hot flashes in patients receiving hormone therapy for prostate cancer It is not yet known whether soy proteinisoflavones are more effective than venlafaxine when given together or with a placebo in treating hot flashes
PURPOSE This randomized phase III trial is studying soy proteinisoflavones and venlafaxine to compare how well they work when given together or with a placebo in treating hot flashes in patients receiving hormone therapy for prostate cancer
PURPOSE This randomized phase III trial is studying soy proteinisoflavones and venlafaxine to compare how well they work when given together or with a placebo in treating hot flashes in patients receiving hormone therapy for prostate cancer
Detailed Description:
OBJECTIVES
Primary
Assess the effect of soy proteinisoflavones and venlafaxine on the hot flash symptom severity score in patients undergoing hormonal manipulation for treatment of prostate cancer
Secondary
Assess the effect of soy proteinisoflavones and venlafaxine on quality of life of these patients
Monitor and assess the participant drop out rate
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to severity of disease metastatic vs nonmetastatic and baseline severity of hot flashes Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive oral placebo pill and oral soy proteinisoflavones powder once daily
Arm II Patients receive oral venlafaxine and oral placebo powder once daily
Arm III Patients receive oral venlafaxine and oral soy proteinisoflavones powder once daily
Arm IV Patients receive oral placebo pill and oral placebo powder once daily Treatment in all arms continues for 12 weeks in the absence of disease progression or unacceptable toxicity After 12 weeks of treatment patients in arms I and III receive a tapered dose of oral venlafaxine once daily for 1 week
Patients complete a vasomotor symptom diary once daily beginning 7 days before the initiation of study treatment and continuing until the completion of study treatment Quality of life is assessed at baseline and at week 12
PROJECTED ACCRUAL A total of 176 patients will be accrued for this study
Primary
Assess the effect of soy proteinisoflavones and venlafaxine on the hot flash symptom severity score in patients undergoing hormonal manipulation for treatment of prostate cancer
Secondary
Assess the effect of soy proteinisoflavones and venlafaxine on quality of life of these patients
Monitor and assess the participant drop out rate
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to severity of disease metastatic vs nonmetastatic and baseline severity of hot flashes Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive oral placebo pill and oral soy proteinisoflavones powder once daily
Arm II Patients receive oral venlafaxine and oral placebo powder once daily
Arm III Patients receive oral venlafaxine and oral soy proteinisoflavones powder once daily
Arm IV Patients receive oral placebo pill and oral placebo powder once daily Treatment in all arms continues for 12 weeks in the absence of disease progression or unacceptable toxicity After 12 weeks of treatment patients in arms I and III receive a tapered dose of oral venlafaxine once daily for 1 week
Patients complete a vasomotor symptom diary once daily beginning 7 days before the initiation of study treatment and continuing until the completion of study treatment Quality of life is assessed at baseline and at week 12
PROJECTED ACCRUAL A total of 176 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| U10CA081851 | NIH | None | httpsreporternihgovquickSearchU10CA081851 |