Soy Protein/Effexor Hormone Therapy for Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Study of Soy Protein and Effexor on Vasomotor Symptoms of Men With Prostate Cancer

Conditions
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Hot Flashes, Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: oral soy protein/isoflavones powder
* Drug: Venlafaxine
* Dietary Supplement: Placebo Powder
* Drug: Placebo Pill


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I - Placebo<br>Patients receive oral placebo pill and oral placebo powder once daily. | Dietary Supplement: Placebo Powder<br>* Placebo powder (20gm casein protein) orally 0 mg of total isoflavones<br>* Other names: Casein;Drug: Placebo Pill<br>* Patients receive oral placebo pill.<br>* Other names: Sugar Pill;|
| Active Comparator: Arm II - Soy<br>Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily. | Dietary Supplement: oral soy protein/isoflavones powder<br>* Soy protein powder (20gm) orally 160 mg of total isoflavones isocaloric supplement of casein protein<br>* Other names: Casein protein;Drug: Placebo Pill<br>* Patients receive oral placebo pill.<br>* Other names: Sugar Pill;|
| Experimental: Arm III - Venlafaxine<br>Patients receive oral Venlafaxine pill and placebo powder once daily. | Drug: Venlafaxine<br>* Patients receive oral venlafaxine 75mg.<br>* Other names: placebo;Dietary Supplement: Placebo Powder<br>* Placebo powder (20gm casein protein) orally 0 mg of total isoflavones<br>* Other names: Casein;|
| Placebo Comparator: Arm IV - Soy + Venlafaxine<br>Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily. | Dietary Supplement: oral soy protein/isoflavones powder<br>* Soy protein powder (20gm) orally 160 mg of total isoflavones isocaloric supplement of casein protein<br>* Other names: Casein protein;Drug: Venlafaxine<br>* Patients receive oral venlafaxine 75mg.<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hot Flash Symptom Severity Score | The primary objective of this randomized trial is to assess the effect of soy and Venlafaxine on the hot flash symptom severity score in men undergoing hormonal manipulation for treatment of prostate cancer. Hot flash severity will be quantitated using the symptom diary (as the sum of the number of hot flashes (any number greater than or equal to 0) times their severity (0=none, 1=mild, 2=moderate, 3=severe)). The primary end point is the 12 week hot flash score relative to the baseline value (i.e., 100*(12 week score)/baseline score). The range is 0 to infinity. Lower values represent a better outcome. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Quality of life is quantified by the Functional Assessment of Cancer Therapy - Prostate questionnaire (FACT-P). The FACT-P consists of four general subscales (functional, emotional, social, and physical) consisting of a total of 27 questions as well as a Prostate specific subscale consisting of 12 questions. Each question is answered on a 0 to 4 scale. The FACT-P score ranges from 0 to 156; higher scores denote better quality of life. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, hot flashes