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View Clinical Trial (Medical Research Study)
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Soy Protein/Isoflavones and Venlafaxine in Treating Hot Flashes in Patients Receiving Hormone Therapy for Prostate Cancer - NCT00354432-27216 (Clinical Trial 146846)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy146846.aspx
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| City: |
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Burlington |
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State:
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NC |
| Zip Code: |
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27216 |
| Conditions: |
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Hot Flashes - Prostate Cancer |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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
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
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 |
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| Study is available at: |
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Alamance Cancer Center at Alamance Regional Medical Center
Burlington, NC 27216
United States
Primary Contact:
Janak K. Choksi, MD
Phone: 336-538-7737 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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