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

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.

Study Type: Interventional

Study Design: Supportive Care, Randomized, Double-Blind

Study Primary Completion Date: February 2010

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.

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 venlafaxine and oral placebo powder once daily. - Arm II: Patients receive oral placebo pill and oral soy protein/isoflavones 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.

Intervention(s) in this Clinical Trial

• Drug: placebo
  • Given orally
• Drug: soy isoflavones
  • Given orally
• Drug: soy protein isolate
  • Given orally
• Drug: venlafaxine
  • Given orally

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm I
  • Patients receive oral venlafaxine and oral placebo powder once daily.
• Active Comparator: Arm II
  • Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
• Experimental: Arm III
  • Patients receive oral venlafaxine and oral soy protein/isoflavones powder once daily.
• Placebo Comparator: Arm IV
  • Patients receive oral placebo pill and oral placebo powder once daily.

Primary Measures

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

Secondary Measures

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

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)
• Hot flash frequency ≥ 4 per day, as defined by sweating, flushing, sensation of warmth, night sweats
• Patient reports overall hot flash severity as moderate to severe

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 intolerance to venlafaxine
• No history of seizure disorder

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)
• 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 or MAOIs
• No concurrent medication to relieve hot flashes
• No other concurrent antidepressant therapy

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Wake Forest University

Overall Clinical Trial Officials and Contacts

Mara Vitolins, DrPH, RD Study Chair Wake Forest University  

Information obtained from ClinicalTrials.gov on October 15, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00354432

Study ID Number: CDR0000489382

ClinicalTrials.gov Identifier: NCT00354432

Health Authority: Unspecified

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