Soy Protein/Effexor Hormone Therapy for Prostate Cancer

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jul 19, 2006

Keywords

ClinConnect Summary

OBJECTIVES:

Primary

* 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 cancer.

Secondary

* 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 trea...

Gender

MALE

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