Soy Protein/Effexor Hormone Therapy for Prostate Cancer
Condition: Hot Flashes; Prostate Cancer
MeSH terms: Prostatic Neoplasms; Hot Flashes
Intervention: oral soy protein/isoflavones powder; Venlafaxine; Placebo Powder; Placebo Pill
Intervention description: Soy protein powder (20gm) orally 160 mg of total isoflavones isocaloric supplement of casein protein; Patients receive oral venlafaxine 75mg.; Placebo powder (20gm casein protein) orally 0 mg of total isoflavones; Patients receive oral placebo pill.
Intervention MeSH terms: Venlafaxine Hydrochloride; Caseins
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: Male
Minimum age: 21 Years
Healthy volunteers: No
Keywords: 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

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic documentation of prostate cancer, any stage Life expectancy of > nine
             months

          -  Prior or current androgen deprivation for treatment or control of prostate cancer to
             include:

          -  Bilateral Orchiectomy

          -  LHRH agonist (with or without antiandrogen therapy) ie: leuprolide (Lupron), goserelin
             (Zoladex), bicalutamide (Casodex), flutamide (Eulexin), or similar agents

          -  Chemotherapy

          -  Radiation (Patients may undergo concurrent radiation therapy to the prostate, prostate
             + seminal vesicles, and/or pelvis). Seed implants are allowed

          -  Participant report of hot flash frequency of an average of four or more per day, as
             defined by sweating, flushing, sensation of warmth, night sweats (Average of 28 per
             week)

          -  Hot flashes must be moderate or severe (See appendix A for hot flash definitions)

          -  Grade 2 (Moderate flashes) are warmer, produce obvious perspiration, and last 2 to 3
             minutes

          -  Grade 3 (Severe flashes) causes profuse perspiration, generate intense heat, last
             longer and interfere with ongoing activity

          -  Age >21

          -  No allergies to soy or dairy products

          -  No current use of SSRIs, SNRI's, MAOIs, or Linezolide

          -  No uncontrolled hypertension (160/90) or greater than Class I American Heart
             Association functional capacity

          -  No history of mania, hypomania, bipolar disorder, or anorexia nervosa

          -  No history of seizures

          -  No history of hepatic dysfunction)

          -  Must have a telephone

          -  Signed protocol-specific Informed Consent

          -  Participants consuming soy foods or soy based supplements must continue on a stable
             regimen during study participation

          -  Patients should maintain same treatment and medications for prostate cancer throughout
             entire study.

          -  No change in treatment for 2 weeks prior to registration.

          -  Current use of medications and herbal supplements for hot flashes are allowed if on a
             stable regimen throughout the entire study. (Does not include anti-depressants)

        Exclusion Criteria:

          -  Anticipated changes in prostate cancer treatment plan (i.e., hormonal manipulation,
             changes in chemotherapy)

          -  Concurrent antidepressant therapy

          -  History of intolerance to venlafaxine

          -  Recent (within 14 days) use of venlafaxine (Effexor XRTM), monoamine oxidase
             inhibitor, SSRI (selective serotonin reuptake inhibitor), or SNRI (selective
             norepinephrine reuptake inhibitor)

          -  History of seizure disorder