NCT00354432

Soy Protein/Effexor Hormone Therapy for Prostate Cancer

Randomized Study of Soy Protein and Effexor on Vasomotor Symptoms of Men With Prostate Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hot Flashes
• Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	oral soy protein/isoflavones powder	Soy protein powder (20gm) orally 160 mg of total isoflavones isocaloric supplement of casein protein
DRUG	Venlafaxine	Patients receive oral venlafaxine 75mg.
DIETARY_SUPPLEMENT	Placebo Powder	Placebo powder (20gm casein protein) orally 0 mg of total isoflavones
DRUG	Placebo Pill	Patients receive oral placebo pill.

Timeline

• Start date: 2007-02-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2006-07-20
• Last updated: 2021-09-28
• Results posted: 2017-05-18

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study