Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

Primary

1. 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

1. Assess the effect of soy protein/isoflavones and venlafaxine on quality of life of these patients.
2. Monitor and assess the participant drop out rate.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

• 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

Patient Characteristics:

• 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

Expected Enrollment

A total of 176 patients will be accrued for this study.

Outcomes

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

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

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.

Trial Contact Information

Trial Lead Organizations

Wake Forest University CCOP Research Base

Mara Vitolins, DrPH, RD, Protocol chair		Ph: 336-716-2886

Registry Information
Official Title		Randomized Study of Soy Protein and Effexor on Vasomotor Symptoms of Men with Prostate Cancer
Trial Start Date		2007-02-15
Trial Completion Date		2010-02-28 (estimated)
Registered in ClinicalTrials.gov		NCT00354432
Date Submitted to PDQ		2006-06-06
Information Last Verified		2010-06-12
NCI Grant/Contract Number		CA81851, CA12197

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