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

Sponsor:	Wake Forest University
Collaborator:	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
Hot Flashes Prostate Cancer	Dietary Supplement: soy isoflavones Dietary Supplement: soy protein isolate Drug: venlafaxine Other: placebo	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Venlafaxine Venlafaxine hydrochloride Proteins, soy

U.S. FDA Resources

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
Active Comparator: Arm I Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.	Drug: venlafaxine Given orally Other: placebo Given orally
Active Comparator: Arm II Patients receive oral venlafaxine and oral placebo powder once daily.	Dietary Supplement: soy isoflavones Given orally Dietary Supplement: soy protein isolate Given orally Other: placebo Given orally
Experimental: Arm III Patients receive oral venlafaxine and oral soy protein/isoflavones powder once daily.	Dietary Supplement: soy isoflavones Given orally Dietary Supplement: soy protein isolate Given orally Drug: venlafaxine Given orally
Placebo Comparator: Arm IV Patients receive oral placebo pill and oral placebo powder once daily.	Other: 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)
  - Seed implants allowed
Hot flash frequency ≥ 4 per day, as defined by sweating, flushing, sensation of warmth, night sweats
- Hot flashes must be moderated (grade 2) or severe (grade 3)
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 hepatic dysfunction
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)
Prior and concurrent stable regimen of soy foods, or soy based supplements allowed
Concurrent stable regimen of herbal supplements for hot flashes allowed
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, SNRIs, MAOIs, or linezolide
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, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Illinois
MBCCOP - JHS Hospital of Cook County
Chicago, Illinois, United States, 60612
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403
United States, Louisiana
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States, 71130-3932
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
CCOP - Beaumont
Royal Oak, Michigan, United States, 48073-6769
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65804
CCOP - Heartland Research Consortium
St. Louis, Missouri, United States, 63131
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, United States, 63141
United States, North Carolina
Alamance Cancer Center at Alamance Regional Medical Center
Burlington, North Carolina, United States, 27216
Southeastern Medical Oncology Center - Goldsboro
Goldsboro, North Carolina, United States, 27534
Caldwell Memorial Hospital
Lenoir, North Carolina, United States, 28645
Wake Forest University CCOP Research Base
Winston-Salem, North Carolina, United States, 27157
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, South Carolina
Cancer Centers of the Carolinas - Easley
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Wisconsin
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54301

Sponsors and Collaborators

Wake Forest University

National Cancer Institute (NCI)

Investigators

Study Chair:

Mara Vitolins, DrPH, RD

Wake Forest University

More Information

Additional Information:

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

No publications provided

Responsible Party:	Edward G. Shaw, Wake Forest University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00354432 History of Changes
Other Study ID Numbers:	CDR0000489382, CCCWFU-97405, CCCWFU-BG05-529
Study First Received:	July 19, 2006
Last Updated:	February 18, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Prostatic Neoplasms
Hot Flashes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms
Venlafaxine
Serotonin Uptake Inhibitors

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012