Prostate Cancer Clinical Trial

Soy Protein/Effexor Hormone Therapy for Prostate Cancer

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.

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Full 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.

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Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

120

Study ID:

NCT00354432

Recruitment Status:

Terminated

Sponsor:

Wake Forest University Health Sciences

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There are 19 Locations for this study

See Locations Near You

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, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
CCOP - Beaumont
Royal Oak Michigan, 48073, United States
CCOP - Heartland Research Consortium
Saint Louis Missouri, 63131, United States
CCOP - St. Louis-Cape Girardeau
Saint Louis Missouri, 63141, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65804, 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 Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States
Wake Forest University CCOP Research Base
Winston-Salem North Carolina, 27157, 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

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

120

Study ID:

NCT00354432

Recruitment Status:

Terminated

Sponsor:


Wake Forest University Health Sciences

How clear is this clinincal trial information?

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