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

Phase 3
21 Years
Not Enrolling
Hot Flashes, Prostate Cancer

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Trial Information

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
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.

Inclusion Criteria


- 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

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

12 week

Safety Issue:


Principal Investigator

Mara Vitolins, DrPH, RD

Investigator Role:

Study Chair

Investigator Affiliation:

Wake Forest University


United States: Federal Government

Study ID:




Start Date:

February 2007

Completion Date:

August 2010

Related Keywords:

  • Hot Flashes
  • Prostate Cancer
  • recurrent prostate cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • hot flashes
  • Prostatic Neoplasms
  • Hot Flashes



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