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Therapeutic Areas: Endocrinology | Obstetrics/Gynecology
Disease Category: Hot Flash

Trial Information

Soy Protein/Isoflavones and Venlafaxine in Treating Hot Flashes in Patients Receiving Hormone Therapy for Prostate Cancer CCCWFU 97405

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.

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)
    • 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

Exclusion Criteria:

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

Patricia Green Sharpe MSN MHSA RN, Director, Department of Clinical Trials/Oncology Data Services
Memorial Health University Medical Center
William & Iffath Hoskins Center for Biomedical Research & Education
4700 Waters Avenue
Savannah, GA 31404
Phone: 912 350-7887
Fax: 912 350-8183
EMail: sharppa1@memorialhealth.com

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