Soy Protein/Effexor Hormone Therapy for Prostate Cancer

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Hot Flashes, Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00354432

Run by

Wake Forest University Health Sciences

People needed

120

Starts

2007-02-01

Expected to finish

2010-08-01

Last updated by the study team

2021-09-28

Who can join

Age: 21 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• CCOP - Christiana Care Health Services — Newark, Delaware, United States
• MBCCOP - JHS Hospital of Cook County — Chicago, Illinois, United States
• CCOP - Central Illinois — Decatur, Illinois, United States
• CCOP - Northern Indiana CR Consortium — South Bend, Indiana, United States
• CCOP - Cedar Rapids Oncology Project — Cedar Rapids, Iowa, United States
• MBCCOP - LSU Health Sciences Center — New Orleans, Louisiana, United States
• Feist-Weiller Cancer Center at Louisiana State University Health Sciences — Shreveport, Louisiana, United States
• CCOP - Michigan Cancer Research Consortium — Ann Arbor, Michigan, United States
• CCOP - Beaumont — Royal Oak, Michigan, United States
• CCOP - Cancer Research for the Ozarks — Springfield, Missouri, United States
• CCOP - Heartland Research Consortium — St Louis, Missouri, United States
• CCOP - St. Louis-Cape Girardeau — St Louis, Missouri, United States
• Alamance Cancer Center at Alamance Regional Medical Center — Burlington, North Carolina, United States
• Southeastern Medical Oncology Center - Goldsboro — Goldsboro, North Carolina, United States
• Caldwell Memorial Hospital — Lenoir, North Carolina, United States
• Wake Forest University Comprehensive Cancer Center — Winston-Salem, North Carolina, United States
• Wake Forest University CCOP Research Base — Winston-Salem, North Carolina, United States
• Cancer Centers of the Carolinas - Easley — Greenville, South Carolina, United States
• CCOP - Upstate Carolina — Spartanburg, South Carolina, United States
• CCOP - St. Vincent Hospital Cancer Center, Green Bay — Green Bay, Wisconsin, United States

Full record on ClinicalTrials.gov

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