Soy Protein/Isoflavones and Venlafaxine in Treating Hot Flashes in Patients Receiving Hormone Therapy for Prostate Cancer
Information source: Wake Forest School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hot Flashes; Prostate Cancer
Intervention: soy isoflavones (Dietary Supplement); soy protein isolate (Dietary Supplement); venlafaxine (Drug); placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Wake Forest School of Medicine Official(s) and/or principal investigator(s): Mara Vitolins, DrPH, RD, Study Chair, Affiliation: Wake Forest School of Medicine
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 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.
Clinical Details
Official title: Randomized Study of Soy Protein and Effexor on Vasomotor Symptoms of Men With Prostate Cancer
Study design: Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Percentage change in the hot flash symptom severity score from baseline to 12 weeks
Secondary outcome: Quality of life as assessed by FACT-P at baseline and at 12 weeks of treatmentAdherence to treatment regimens
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
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 treatment arms.
- Arm I: Patients receive oral placebo pill and oral soy protein/isoflavones powder once
daily.
- Arm II: Patients receive oral venlafaxine and oral placebo powder once daily.
- Arm III: Patients receive oral venlafaxine and oral soy protein/isoflavones powder once
daily.
- Arm IV: Patients receive oral placebo pill and oral placebo powder once daily.
Treatment in all arms continues for 12 weeks in the absence of disease progression or
unacceptable toxicity. After 12 weeks of treatment, patients in arms I and III receive
a tapered dose of oral venlafaxine once daily for 1 week.
Patients complete a vasomotor symptom diary once daily beginning 7 days before the
initiation of study treatment and continuing until the completion of study treatment.
Quality of life is assessed at baseline and at week 12.
PROJECTED ACCRUAL: A total of 176 patients will be accrued for this study.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
DISEASE CHARACTERISTICS:
- Histologically confirmed prostate cancer
- Any stage disease allowed
- Undergoing or underwent androgen deprivation for treatment or control of prostate
cancer including any of the following:
- Bilateral orchiectomy
- Luteinizing hormone-releasing hormone (LHRH) agonist therapy (e. g., leuprolide,
goserelin, bicalutamide, flutamide, or similar agents) with or without
antiandrogen therapy
- Chemotherapy
- Radiotherapy (patients may undergo concurrent radiotherapy to the prostate,
prostate and seminal vesicles, and/or pelvis)
- Seed implants allowed
- Hot flash frequency ≥ 4 per day, as defined by sweating, flushing, sensation of
warmth, night sweats
- Hot flashes must be moderated (grade 2) or severe (grade 3)
- Patient reports overall hot flash severity as moderate to severe
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 9 months
- Bilirubin < 2 mg/dL
- AST ≤ 2 times normal
- Must have a telephone
- No allergies to soy or dairy products
- No uncontrolled hypertension (i. e., BP 160/90 mm Hg) or American Heart Association
functional capacity ≥ class I
- No history of mania, hypomania, bipolar disorder, or anorexia nervosa
- No history of seizures
- No history of hepatic dysfunction
- No history of intolerance to venlafaxine
- No history of seizure disorder
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 14 days since prior venlafaxine, monoamine oxidase inhibitor (MAOI),
selective serotonin reuptake inhibitor (SSRI), or selective norepinephrine reuptake
inhibitor (SNRI)
- Prior and concurrent stable regimen of soy foods, or soy based supplements allowed
- Concurrent stable regimen of herbal supplements for hot flashes allowed
- No concurrent chemotherapy, radiotherapy, or surgery
- No concurrent estrogen, progestational agents, corticosteroids, androgens, or other
medications (such as clonidine or bellamine) directed at alleviating hot flashes
- No concurrent SSRIs, SNRIs, MAOIs, or linezolide
- No concurrent medication to relieve hot flashes
- No other concurrent antidepressant therapy
Locations and Contacts
CCOP - Christiana Care Health Services, Newark, Delaware 19713, United States
MBCCOP - JHS Hospital of Cook County, Chicago, Illinois 60612, United States
CCOP - Central Illinois, Decatur, Illinois 62526, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana 46601, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana 70112, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences, Shreveport, Louisiana 71130-3932, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48106, United States
CCOP - Beaumont, Royal Oak, Michigan 48073-6769, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri 65804, United States
CCOP - Heartland Research Consortium, St. Louis, Missouri 63131, United States
CCOP - St. Louis-Cape Girardeau, St. Louis, Missouri 63141, United States
Alamance Cancer Center at Alamance Regional Medical Center, Burlington, North Carolina 27216, United States
Southeastern Medical Oncology Center - Goldsboro, Goldsboro, North Carolina 27534, United States
Caldwell Memorial Hospital, Lenoir, North Carolina 28645, United States
Wake Forest University CCOP Research Base, Winston-Salem, North Carolina 27157, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina 27157-1096, United States
Cancer Centers of the Carolinas - Easley, Greenville, South Carolina 29615, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin 54301, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: February 2007
Last updated: June 26, 2012
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