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Soy Protein/Isoflavones and Venlafaxine in Treating Hot Flashes in Patients Receiving Hormone Therapy for Prostate Cancer

Information source: Wake Forest School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hot Flashes; Prostate Cancer

Intervention: soy isoflavones (Dietary Supplement); soy protein isolate (Dietary Supplement); venlafaxine (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Wake Forest School of Medicine

Official(s) and/or principal investigator(s):
Mara Vitolins, DrPH, RD, Study Chair, Affiliation: Wake Forest School of Medicine


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 Details

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

Study design: Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome: Percentage change in the hot flash symptom severity score from baseline to 12 weeks

Secondary outcome:

Quality of life as assessed by FACT-P at baseline and at 12 weeks of treatment

Adherence to treatment regimens

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


- 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.


Minimum age: 21 Years. Maximum age: N/A. Gender(s): Male.



- Histologically confirmed prostate cancer

- Any stage disease allowed

- Undergoing or underwent androgen deprivation for treatment or control of prostate

cancer including any of the following:

- Bilateral orchiectomy

- Luteinizing hormone-releasing hormone (LHRH) agonist therapy (e. g., leuprolide,

goserelin, bicalutamide, flutamide, or similar agents) with or without antiandrogen therapy

- Chemotherapy

- Radiotherapy (patients may undergo concurrent radiotherapy to the prostate,

prostate and seminal vesicles, and/or pelvis)

- Seed implants allowed

- Hot flash frequency ≥ 4 per day, as defined by sweating, flushing, sensation of

warmth, night sweats

- Hot flashes must be moderated (grade 2) or severe (grade 3)

- Patient reports overall hot flash severity as moderate to severe


- Life expectancy ≥ 9 months

- Bilirubin < 2 mg/dL

- AST ≤ 2 times normal

- Must have a telephone

- No allergies to soy or dairy products

- No uncontrolled hypertension (i. e., BP 160/90 mm Hg) or American Heart Association

functional capacity ≥ class I

- No history of mania, hypomania, bipolar disorder, or anorexia nervosa

- No history of seizures

- No history of hepatic dysfunction

- No history of intolerance to venlafaxine

- No history of seizure disorder


- See Disease Characteristics

- More than 14 days since prior venlafaxine, monoamine oxidase inhibitor (MAOI),

selective serotonin reuptake inhibitor (SSRI), or selective norepinephrine reuptake inhibitor (SNRI)

- Prior and concurrent stable regimen of soy foods, or soy based supplements allowed

- Concurrent stable regimen of herbal supplements for hot flashes allowed

- No concurrent chemotherapy, radiotherapy, or surgery

- No concurrent estrogen, progestational agents, corticosteroids, androgens, or other

medications (such as clonidine or bellamine) directed at alleviating hot flashes

- No concurrent SSRIs, SNRIs, MAOIs, or linezolide

- No concurrent medication to relieve hot flashes

- No other concurrent antidepressant therapy

Locations and Contacts

CCOP - Christiana Care Health Services, Newark, Delaware 19713, United States

MBCCOP - JHS Hospital of Cook County, Chicago, Illinois 60612, United States

CCOP - Central Illinois, Decatur, Illinois 62526, United States

CCOP - Northern Indiana CR Consortium, South Bend, Indiana 46601, United States

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403, United States

MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana 70112, United States

Feist-Weiller Cancer Center at Louisiana State University Health Sciences, Shreveport, Louisiana 71130-3932, United States

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48106, United States

CCOP - Beaumont, Royal Oak, Michigan 48073-6769, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri 65804, United States

CCOP - Heartland Research Consortium, St. Louis, Missouri 63131, United States

CCOP - St. Louis-Cape Girardeau, St. Louis, Missouri 63141, United States

Alamance Cancer Center at Alamance Regional Medical Center, Burlington, North Carolina 27216, United States

Southeastern Medical Oncology Center - Goldsboro, Goldsboro, North Carolina 27534, United States

Caldwell Memorial Hospital, Lenoir, North Carolina 28645, United States

Wake Forest University CCOP Research Base, Winston-Salem, North Carolina 27157, United States

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina 27157-1096, United States

Cancer Centers of the Carolinas - Easley, Greenville, South Carolina 29615, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States

CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin 54301, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: February 2007
Last updated: June 26, 2012

Page last updated: August 23, 2015

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