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

Inclusion 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

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

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