Soy Protein/Effexor Hormone Therapy for Prostate Cancer

• Status: Terminated
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Caseins; Venlafaxine Hydrochloride

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