Soy Protein/Isoflavones and Venlafaxine in Treating Hot Flashes in Patients Receiving Hormone Therapy for Prostate Cancer - Full Text View

Sponsors and Collaborators:	Wake Forest University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00354432

Purpose

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.

Condition	Intervention	Phase
Cancer-Related Problem/Condition Prostate Cancer	Drug: placebo Drug: soy isoflavones Drug: soy protein isolate Drug: venlafaxine	Phase III

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Venlafaxine Venlafaxine hydrochloride Proteins, soy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind
Official Title:	Randomized Study of Soy Protein and Effexor on Vasomotor Symptoms of Men With Prostate Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Percentage change in the hot flash symptom severity score from baseline to 12 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life as assessed by FACT-P at baseline and at 12 weeks of treatment [ Designated as safety issue: No ]
Adherence to treatment regimens [ Designated as safety issue: No ]

Estimated Enrollment:	176
Study Start Date:	February 2007
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Active Comparator Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.	Drug: placebo Given orally Drug: venlafaxine Given orally
Arm II: Active Comparator Patients receive oral venlafaxine and oral placebo powder once daily.	Drug: placebo Given orally Drug: soy isoflavones Given orally Drug: soy protein isolate Given orally
Arm III: Experimental Patients receive oral venlafaxine and oral soy protein/isoflavones powder once daily.	Drug: soy isoflavones Given orally Drug: soy protein isolate Given orally Drug: venlafaxine Given orally
Arm IV: Placebo Comparator Patients receive oral placebo pill and oral placebo powder once daily.	Drug: placebo Given orally

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

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354432

Locations

United States, California
CCOP - Santa Rosa Memorial Hospital	Recruiting
Santa Rosa, California, United States, 95403
Contact: Ian C. Anderson, MD 707-521-3830
United States, Delaware
CCOP - Christiana Care Health Services	Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services 302-733-6227
United States, Florida
CCOP - Mount Sinai Medical Center	Recruiting
Miami Beach, Florida, United States, 33140
Contact: Rogerio C. Lilenbaum, MD 305-674-2625
University of Miami Sylvester Comprehensive Cancer Center - Miami	Recruiting
Miami, Florida, United States, 33136
Contact: University of Miami Sylvester Comprehensive Cancer Center Clin 866-574-5124 Sylvester@emergingmed.com
United States, Illinois
CCOP - Central Illinois	Recruiting
Decatur, Illinois, United States, 62526
Contact: James L. Wade, MD 217-876-6617 jlwade3@sbcglobal.net
MBCCOP - JHS Hospital of Cook County	Recruiting
Chicago, Illinois, United States, 60612
Contact: Karen Carter, BS 312-864-5204
United States, Indiana
CCOP - Northern Indiana CR Consortium	Recruiting
South Bend, Indiana, United States, 46601
Contact: Mary Jean Wasielewski 574-647-7370 mwasielewski@memorialsb.org
United States, Iowa
CCOP - Cedar Rapids Oncology Project	Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Kathy Fleming 319-363-2690 ext. 323
United States, Louisiana
Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Recruiting
Shreveport, Louisiana, United States, 71130-3932
Contact: Glenn M. Mills, MD 318-813-1442 gmills@lsuhsc.edu
MBCCOP - LSU Health Sciences Center	Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Robert W. Veith, MD 504-896-9740
United States, Michigan
CCOP - Beaumont	Recruiting
Royal Oak, Michigan, United States, 48073-6769
Contact: David A. Decker, MD, FACP 248-551-6900 ddecker@beaumont.edu
CCOP - Michigan Cancer Research Consortium	Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Philip J. Stella, MD 734-712-1000
United States, Missouri
CCOP - Cancer Research for the Ozarks	Recruiting
Springfield, Missouri, United States, 65804
Contact: John W. Goodwin, MD 417-889-8099 jgoodwin@sprg.mercy.net
CCOP - Heartland Research Consortium	Recruiting
St. Louis, Missouri, United States, 63131
Contact: Alan P. Lyss, MD 314-996-5569 jmr2166@bjc.org
CCOP - St. Louis-Cape Girardeau	Recruiting
St. Louis, Missouri, United States, 63141
Contact: Bethany G. Sleckman, MD 314-251-6573
United States, North Carolina
Alamance Cancer Center at Alamance Regional Medical Center	Recruiting
Burlington, North Carolina, United States, 27216
Contact: Janak K. Choksi, MD 336-538-7737
Caldwell Memorial Hospital	Recruiting
Lenoir, North Carolina, United States, 28645
Contact: Theodore E. Yaeger, MD, FACRO 828-759-4960
Southeastern Medical Oncology Center - Goldsboro	Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD 919-580-0000 jatkins@cancersmoc.com
Wake Forest University CCOP Research Base	Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Mara Vitolins, DrPH, RD 336-716-2886
Wake Forest University Comprehensive Cancer Center	Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771
United States, South Carolina
Cancer Centers of the Carolinas - Easley	Recruiting
Greenville, South Carolina, United States, 29615
Contact: Jeffrey K. Giguere, MD, FACP 864-241-6251 Jeffrey.Giguere@usoncology.com
CCOP - Upstate Carolina	Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Clinical Trials Office - CCOP - Upstate Carolina 800-486-5941

Sponsors and Collaborators

Wake Forest University

National Cancer Institute (NCI)

Investigators

Study Chair:

Mara Vitolins, DrPH, RD

Wake Forest University

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000489382, CCCWFU-97405, CCCWFU-BG05-529
Study First Received:	July 19, 2006
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00354432
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer

stage III prostate cancer
stage IV prostate cancer
hot flashes

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Venlafaxine
Hot Flashes
Urogenital Neoplasms

Genital Diseases, Male
Prostatic Neoplasms
Serotonin
Recurrence

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 14, 2009