Soy Protein/Effexor Hormone Therapy for Prostate Cancer

Phase 3

Terminated

Conditions: Hot Flashes
Prostate Cancer

Interventions: Dietary Supplement: Placebo Powder
Drug: Venlafaxine
Dietary Supplement: oral soy protein/isoflavones powder
Drug: Placebo Pill

Registration Number: NCT00354432

Lead Sponsor: Wake Forest University Health Sciences

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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Male

Target Recruitment: 120

Inclusion Criteria

Histologic documentation of prostate cancer, any stage Life expectancy of > nine months
Prior or current androgen deprivation for treatment or control of prostate cancer to include:
Bilateral Orchiectomy
LHRH agonist (with or without antiandrogen therapy) ie: leuprolide (Lupron), goserelin (Zoladex), bicalutamide (Casodex), flutamide (Eulexin), or similar agents
Chemotherapy
Radiation (Patients may undergo concurrent radiation therapy to the prostate, prostate + seminal vesicles, and/or pelvis). Seed implants are allowed
Participant report of hot flash frequency of an average of four or more per day, as defined by sweating, flushing, sensation of warmth, night sweats (Average of 28 per week)
Hot flashes must be moderate or severe (See appendix A for hot flash definitions)
Grade 2 (Moderate flashes) are warmer, produce obvious perspiration, and last 2 to 3 minutes
Grade 3 (Severe flashes) causes profuse perspiration, generate intense heat, last longer and interfere with ongoing activity
Age >21
No allergies to soy or dairy products
No current use of SSRIs, SNRI's, MAOIs, or Linezolide
No uncontrolled hypertension (160/90) or greater than Class I American Heart Association functional capacity
No history of mania, hypomania, bipolar disorder, or anorexia nervosa
No history of seizures
No history of hepatic dysfunction)
Must have a telephone
Signed protocol-specific Informed Consent
Participants consuming soy foods or soy based supplements must continue on a stable regimen during study participation
Patients should maintain same treatment and medications for prostate cancer throughout entire study.
No change in treatment for 2 weeks prior to registration.
Current use of medications and herbal supplements for hot flashes are allowed if on a stable regimen throughout the entire study. (Does not include anti-depressants)

Exclusion Criteria

Anticipated changes in prostate cancer treatment plan (i.e., hormonal manipulation, changes in chemotherapy)
Concurrent antidepressant therapy
History of intolerance to venlafaxine
Recent (within 14 days) use of venlafaxine (Effexor XRTM), monoamine oxidase inhibitor, SSRI (selective serotonin reuptake inhibitor), or SNRI (selective norepinephrine reuptake inhibitor)
History of seizure disorder

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm I - Placebo	Placebo Powder	Patients receive oral placebo pill and oral placebo powder once daily.
Arm III - Venlafaxine	Venlafaxine	Patients receive oral Venlafaxine pill and placebo powder once daily.
Arm III - Venlafaxine	Placebo Powder	Patients receive oral Venlafaxine pill and placebo powder once daily.
Arm IV - Soy + Venlafaxine	oral soy protein/isoflavones powder	Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
Arm I - Placebo	Placebo Pill	Patients receive oral placebo pill and oral placebo powder once daily.
Arm II - Soy	oral soy protein/isoflavones powder	Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
Arm II - Soy	Placebo Pill	Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
Arm IV - Soy + Venlafaxine	Venlafaxine	Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.

Primary Outcome Measures

Name	Time	Method
Hot Flash Symptom Severity Score	12 weeks	The primary objective of this randomized trial is to assess the effect of soy and Venlafaxine on the hot flash symptom severity score in men undergoing hormonal manipulation for treatment of prostate cancer. Hot flash severity will be quantitated using the symptom diary (as the sum of the number of hot flashes (any number greater than or equal to 0) times their severity (0=none, 1=mild, 2=moderate, 3=severe)). The primary end point is the 12 week hot flash score relative to the baseline value (i.e., 100\*(12 week score)/baseline score). The range is 0 to infinity. Lower values represent a better outcome.

Secondary Outcome Measures

Name	Time	Method
Quality of Life	12 weeks	Quality of life is quantified by the Functional Assessment of Cancer Therapy - Prostate questionnaire (FACT-P). The FACT-P consists of four general subscales (functional, emotional, social, and physical) consisting of a total of 27 questions as well as a Prostate specific subscale consisting of 12 questions. Each question is answered on a 0 to 4 scale. The FACT-P score ranges from 0 to 156; higher scores denote better quality of life.

Trial Locations

Locations (20): CCOP - Heartland Research Consortium
🇺🇸
Saint Louis, Missouri, United States
MBCCOP - JHS Hospital of Cook County
🇺🇸
Chicago, Illinois, United States
CCOP - Northern Indiana CR Consortium
🇺🇸
South Bend, Indiana, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
🇺🇸
Shreveport, Louisiana, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸
Green Bay, Wisconsin, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸
Winston-Salem, North Carolina, United States
Wake Forest University CCOP Research Base
🇺🇸
Winston-Salem, North Carolina, United States
Cancer Centers of the Carolinas - Easley
🇺🇸
Greenville, South Carolina, United States
MBCCOP - LSU Health Sciences Center
🇺🇸
New Orleans, Louisiana, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸
Cedar Rapids, Iowa, United States
CCOP - Christiana Care Health Services
🇺🇸
Newark, Delaware, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸
Saint Louis, Missouri, United States
CCOP - Beaumont
🇺🇸
Royal Oak, Michigan, United States
CCOP - Upstate Carolina
🇺🇸
Spartanburg, South Carolina, United States
CCOP - Central Illinois
🇺🇸
Decatur, Illinois, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸
Ann Arbor, Michigan, United States
Caldwell Memorial Hospital
🇺🇸
Lenoir, North Carolina, United States
Southeastern Medical Oncology Center - Goldsboro
🇺🇸
Goldsboro, North Carolina, United States
CCOP - Cancer Research for the Ozarks
🇺🇸
Springfield, Missouri, United States
Alamance Cancer Center at Alamance Regional Medical Center
🇺🇸
Burlington, North Carolina, United States