Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-02 @ 4:47 AM
Study NCT ID:
NCT00354432
Status:
TERMINATED
Last Update Posted:
2021-09-28
First Post:
2006-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Soy Protein/Effexor Hormone Therapy for Prostate Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
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 protein/isoflavones and venlafaxine may help relieve hot flashes in patients receiving hormone therapy for prostate cancer. It is not yet known whether soy protein/isoflavones 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 protein/isoflavones 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 protein/isoflavones 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 protein/isoflavones 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 protein/isoflavones 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 protein/isoflavones powder once daily.
* Arm II: Patients receive oral venlafaxine and oral placebo powder once daily.
* Arm III: Patients receive oral venlafaxine and oral soy protein/isoflavones 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 protein/isoflavones 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 protein/isoflavones 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 protein/isoflavones powder once daily.
* Arm II: Patients receive oral venlafaxine and oral placebo powder once daily.
* Arm III: Patients receive oral venlafaxine and oral soy protein/isoflavones 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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U10CA081851 | NIH | None | https://reporter.nih.gov/quic… | View |