Randomized Study of Soy Protein and Effexor on Vasomotor Symptoms of Men With Prostate Cancer
- 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
- Assess the effect of soy protein/isoflavones and venlafaxine on quality of life of
- 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
- 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
- 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.
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Percentage change in the hot flash symptom severity score from baseline to 12 weeks
Mara Vitolins, DrPH, RD
Wake Forest University
United States: Federal Government
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|CCOP - Michigan Cancer Research Consortium||Ann Arbor, Michigan 48106|
|CCOP - Cedar Rapids Oncology Project||Cedar Rapids, Iowa 52403-1206|
|CCOP - Central Illinois||Springfield, Illinois 62526|
|CCOP - Cancer Research for the Ozarks||Springfield, Missouri 65807|
|CCOP - Northern Indiana CR Consortium||South Bend, Indiana 46601|
|CCOP - St. Vincent Hospital Cancer Center, Green Bay||Green Bay, Wisconsin 54301|
|MBCCOP - LSU Health Sciences Center||New Orleans, Louisiana 70112|
|CCOP - St. Louis-Cape Girardeau||Saint Louis, Missouri 63141|
|CCOP - Beaumont||Royal Oak, Michigan 48073-6769|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|Feist-Weiller Cancer Center at Louisiana State University Health Sciences||Shreveport, Louisiana 71130-3932|
|Alamance Cancer Center at Alamance Regional Medical Center||Burlington, North Carolina 27216|
|Cancer Centers of the Carolinas - Easley||Easley, South Carolina 29640|
|MBCCOP - JHS Hospital of Cook County||Chicago, Illinois 60612|
|Caldwell Memorial Hospital||Lenoir, North Carolina 28645|
|Southeastern Medical Oncology Center - Goldsboro||Goldsboro, North Carolina 27534|
|CCOP - Heartland Research Consortium||St. Louis, Missouri 63131|
|Wake Forest University CCOP Research Base||Winston-Salem, North Carolina 27157|