Status:
TERMINATED
Soy Protein/Effexor Hormone Therapy for Prostate Cancer
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hot Flashes
Prostate Cancer
Eligibility:
MALE
21+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
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 canc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00354432
Start Date
February 1 2007
End Date
August 1 2010
Last Update
September 28 2021
Active Locations (20)
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1
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
2
MBCCOP - JHS Hospital of Cook County
Chicago, Illinois, United States, 60612
3
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
4
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601