Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT00354432
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
21 Years
Study:
NCT00354432
Study Brief:
Protocol Section:
NCT00354432