Soy Protein/Effexor Hormone Therapy for Prostate Cancer

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00354432
Study type	Interventional
Source	Wake Forest University Health Sciences
Contact
Status	Terminated
Phase	Phase 3
Start date	February 1, 2007
Completion date	August 1, 2010

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.