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Phase III Randomized Study of Soy Protein/Isoflavones and Venlafaxine on Vasomotor Symptoms in Patients With Prostate Cancer Undergoing Hormonal Manipulation
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Soy Protein/Isoflavones and Venlafaxine in Treating Hot Flashes in Patients Receiving Hormone Therapy for Prostate Cancer
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
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| Phase III | Supportive care | Active | 21 and over | CCCWFU-97405
CCCWFU 97405, WFU-97405, CCCWFU-BG05-529, NCT00354432 |
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.
Entry 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)
- Hot flash frequency ≥ 4 per day, as defined by sweating, flushing, sensation of warmth, night sweats
- Patient reports overall hot flash severity as moderate to severe
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)
- 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 or MAOIs
- No concurrent medication to relieve hot flashes
- No other concurrent antidepressant therapy
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 intolerance to venlafaxine
- No history of seizure disorder
Expected Enrollment 176A total of 176 patients will be accrued for this study. Outcomes Primary Outcome(s)Percentage change in the hot flash symptom severity score from baseline to 12 weeks
Secondary Outcome(s)Quality of life as assessed by FACT-P at baseline and at 12 weeks of treatment
Adherence to treatment regimens
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.
Trial Contact Information
Trial Lead Organizations Wake Forest University CCOP Research Base | | | | Mara Vitolins, DrPH, RD, Protocol chair | | | |
Trial Sites
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| U.S.A. |
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| Delaware |
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Newark |
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| | | | | | | | | CCOP - Christiana Care Health Services |
| | | Clinical Trial Office - CCOP - Christiana Care Health Services | |
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| Illinois |
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Chicago |
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| | | | MBCCOP - JHS Hospital of Cook County |
| | | Karen Carter, BS | |
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Decatur |
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| | | CCOP - Central Illinois |
| | | James Wade, MD | |
| | Email:
jlwade3@sbcglobal.net |
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| Indiana |
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South Bend |
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| | | | CCOP - Northern Indiana CR Consortium |
| | | Mary Jean Wasielewski | | Ph: | 574-647-7370 | | 800-284-7370 |
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| | Email:
mwasielewski@memorialsb.org |
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| Iowa |
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Cedar Rapids |
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| | | | CCOP - Cedar Rapids Oncology Project |
| | | Kathy Fleming | | Ph: | 319-363-2690 ext. 323 | | |
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| Louisiana |
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New Orleans |
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| | | | MBCCOP - LSU Health Sciences Center |
| | | Robert Veith, MD | |
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Shreveport |
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| | | Feist-Weiller Cancer Center at Louisiana State University Health Sciences |
| | | Glenn Mills, MD | |
| | Email:
gmills@lsuhsc.edu |
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| Michigan |
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Ann Arbor |
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| | | | CCOP - Michigan Cancer Research Consortium |
| | | Philip Stella, MD | |
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Royal Oak |
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| | | CCOP - Beaumont |
| | | David Decker, MD, FACP | |
| | Email:
ddecker@beaumont.edu |
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| Missouri |
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Springfield |
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| | | | CCOP - Cancer Research for the Ozarks |
| | | John Goodwin, MD | |
| | Email:
jgoodwin@sprg.mercy.net |
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St. Louis |
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| | | CCOP - Heartland Research Consortium |
| | | Alan Lyss, MD | |
| | Email:
jmr2166@bjc.org |
| | | CCOP - St. Louis-Cape Girardeau |
| | | Bethany Sleckman, MD | |
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| North Carolina |
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Burlington |
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| | | | Alamance Cancer Center at Alamance Regional Medical Center |
| | | Janak Choksi, MD | |
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Goldsboro |
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| | | Southeastern Medical Oncology Center - Goldsboro |
| | | James Atkins, MD | |
| | Email:
jatkins@cancersmoc.com |
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Lenoir |
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| | | Caldwell Memorial Hospital |
| | | Theodore Yaeger, MD, FACRO | |
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Winston-Salem |
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| | | Wake Forest University CCOP Research Base |
| | | Mara Vitolins, DrPH, RD | |
| | | Wake Forest University Comprehensive Cancer Center |
| | | Clinical Trials Office - Wake Forest University Comprehensive Cancer Center | |
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| South Carolina |
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Greenville |
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| | | | Cancer Centers of the Carolinas - Easley |
| | | Jeffrey Giguere, MD, FACP | |
| | Email:
Jeffrey.Giguere@usoncology.com |
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Spartanburg |
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| | | CCOP - Upstate Carolina |
| | | Clinical Trials Office - CCOP - Upstate Carolina | |
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| Wisconsin |
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Green Bay |
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| | | | CCOP - St. Vincent Hospital Cancer Center, Green Bay |
| | | Clinical Trials Office - CCOP - St. Vincent Hospital Cancer Center, Green Bay | |
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| Registry Information | | | Official Title | | Randomized Study of Soy Protein and Effexor on Vasomotor Symptoms of Men with Prostate Cancer | | | Trial Start Date | | 2007-02-15 | | | Trial Completion Date | | 2010-02-28 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00354432 | | | Date Submitted to PDQ | | 2006-06-06 | | | Information Last Verified | | 2009-11-26 | | | NCI Grant/Contract Number | | CA81851, CA12197 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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