Soy Protein/Effexor Hormone Therapy for Prostate Cancer

September 7, 2021 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • CCOP - Christiana Care Health Services
    • Illinois
      • Chicago, Illinois, United States, 60612
        • MBCCOP - JHS Hospital of Cook County
      • Decatur, Illinois, United States, 62526
        • CCOP - Central Illinois
    • Indiana
      • South Bend, Indiana, United States, 46601
        • CCOP - Northern Indiana CR Consortium
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
        • CCOP - Cedar Rapids Oncology Project
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • MBCCOP - LSU Health Sciences Center
      • Shreveport, Louisiana, United States, 71130-3932
        • Feist-Weiller Cancer Center at Louisiana State University Health Sciences
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Royal Oak, Michigan, United States, 48073-6769
        • CCOP - Beaumont
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Saint Louis, Missouri, United States, 63131
        • CCOP - Heartland Research Consortium
      • Springfield, Missouri, United States, 65804
        • CCOP - Cancer Research for the Ozarks
    • North Carolina
      • Burlington, North Carolina, United States, 27216
        • Alamance Cancer Center at Alamance Regional Medical Center
      • Goldsboro, North Carolina, United States, 27534
        • Southeastern Medical Oncology Center - Goldsboro
      • Lenoir, North Carolina, United States, 28645
        • Caldwell Memorial Hospital
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University CCOP Research Base
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Cancer Centers of the Carolinas - Easley
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • CCOP - St. Vincent Hospital Cancer Center, Green Bay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Arm I - Placebo
Patients receive oral placebo pill and oral placebo powder once daily.
Dietary supplement: Placebo Powder
Placebo powder (20gm casein protein) orally 0 mg of total isoflavones
Other Names:
  • Casein
Drug: Placebo Pill
Patients receive oral placebo pill.
Other Names:
  • Sugar Pill
ACTIVE_COMPARATOR: Arm II - Soy
Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
Drug: Placebo Pill
Patients receive oral placebo pill.
Other Names:
  • Sugar Pill
Dietary supplement: oral soy protein/isoflavones powder
Soy protein powder (20gm) orally 160 mg of total isoflavones isocaloric supplement of casein protein
Other Names:
  • Protein powder
  • Supplement powder soy and casein 20gm
  • Isoflavones
  • Isocaloric supplement
  • Casein protein
EXPERIMENTAL: Arm III - Venlafaxine
Patients receive oral Venlafaxine pill and placebo powder once daily.
Dietary supplement: Placebo Powder
Placebo powder (20gm casein protein) orally 0 mg of total isoflavones
Other Names:
  • Casein
Drug: Venlafaxine
Patients receive oral venlafaxine 75mg.
Other Names:
  • placebo
  • Effexor XR
PLACEBO_COMPARATOR: Arm IV - Soy + Venlafaxine
Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
Dietary supplement: oral soy protein/isoflavones powder
Soy protein powder (20gm) orally 160 mg of total isoflavones isocaloric supplement of casein protein
Other Names:
  • Protein powder
  • Supplement powder soy and casein 20gm
  • Isoflavones
  • Isocaloric supplement
  • Casein protein
Drug: Venlafaxine
Patients receive oral venlafaxine 75mg.
Other Names:
  • placebo
  • Effexor XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hot Flash Symptom Severity Score
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Mara Vitolins, DrPH, RD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2007

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

July 19, 2006

First Submitted That Met QC Criteria

July 19, 2006

First Posted (ESTIMATE)

July 20, 2006

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 7, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REBAcccwfu97405
  • U10CA081851 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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