Soy Protein/Effexor Hormone Therapy for Prostate Cancer
Hot Flashes, Prostate Cancer
About this trial
This is an interventional supportive care trial for Hot Flashes focused on measuring 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
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
Sites / Locations
- CCOP - Christiana Care Health Services
- MBCCOP - JHS Hospital of Cook County
- CCOP - Central Illinois
- CCOP - Northern Indiana CR Consortium
- CCOP - Cedar Rapids Oncology Project
- MBCCOP - LSU Health Sciences Center
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
- CCOP - Michigan Cancer Research Consortium
- CCOP - Beaumont
- CCOP - Heartland Research Consortium
- CCOP - St. Louis-Cape Girardeau
- CCOP - Cancer Research for the Ozarks
- Alamance Cancer Center at Alamance Regional Medical Center
- Southeastern Medical Oncology Center - Goldsboro
- Caldwell Memorial Hospital
- Wake Forest University Comprehensive Cancer Center
- Wake Forest University CCOP Research Base
- Cancer Centers of the Carolinas - Easley
- CCOP - Upstate Carolina
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Experimental
Placebo Comparator
Arm I - Placebo
Arm II - Soy
Arm III - Venlafaxine
Arm IV - Soy + Venlafaxine
Patients receive oral placebo pill and oral placebo powder once daily.
Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
Patients receive oral Venlafaxine pill and placebo powder once daily.
Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.