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


Phase 3
21 Years
N/A
Not Enrolling
Male
Hot Flashes, Prostate Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Percentage change in the hot flash symptom severity score from baseline to 12 weeks

Outcome Time Frame:

12 week

Safety Issue:

No

Principal Investigator

Mara Vitolins, DrPH, RD

Investigator Role:

Study Chair

Investigator Affiliation:

Wake Forest University

Authority:

United States: Federal Government

Study ID:

cccwfu97405

NCT ID:

NCT00354432

Start Date:

February 2007

Completion Date:

August 2010

Related Keywords:

  • Hot Flashes
  • Prostate Cancer
  • 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
  • Prostatic Neoplasms
  • Hot Flashes

Name

Location

CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Feist-Weiller Cancer Center at Louisiana State University Health SciencesShreveport, Louisiana  71130-3932
Alamance Cancer Center at Alamance Regional Medical CenterBurlington, North Carolina  27216
Cancer Centers of the Carolinas - EasleyEasley, South Carolina  29640
MBCCOP - JHS Hospital of Cook CountyChicago, Illinois  60612
Caldwell Memorial HospitalLenoir, North Carolina  28645
Southeastern Medical Oncology Center - GoldsboroGoldsboro, North Carolina  27534
CCOP - Heartland Research ConsortiumSt. Louis, Missouri  63131
Wake Forest University CCOP Research BaseWinston-Salem, North Carolina  27157