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Soy Protein/Effexor Hormone Therapy for Prostate Cancer

Primary Purpose

Hot Flashes, Prostate Cancer

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
oral soy protein/isoflavones powder
Venlafaxine
Placebo Powder
Placebo Pill
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hot Flashes focused on measuring 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

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • CCOP - Christiana Care Health Services
  • MBCCOP - JHS Hospital of Cook County
  • CCOP - Central Illinois
  • CCOP - Northern Indiana CR Consortium
  • CCOP - Cedar Rapids Oncology Project
  • MBCCOP - LSU Health Sciences Center
  • Feist-Weiller Cancer Center at Louisiana State University Health Sciences
  • CCOP - Michigan Cancer Research Consortium
  • CCOP - Beaumont
  • CCOP - Heartland Research Consortium
  • CCOP - St. Louis-Cape Girardeau
  • CCOP - Cancer Research for the Ozarks
  • Alamance Cancer Center at Alamance Regional Medical Center
  • Southeastern Medical Oncology Center - Goldsboro
  • Caldwell Memorial Hospital
  • Wake Forest University Comprehensive Cancer Center
  • Wake Forest University CCOP Research Base
  • Cancer Centers of the Carolinas - Easley
  • CCOP - Upstate Carolina
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Placebo Comparator

Arm Label

Arm I - Placebo

Arm II - Soy

Arm III - Venlafaxine

Arm IV - Soy + Venlafaxine

Arm Description

Patients receive oral placebo pill and oral placebo powder once daily.

Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.

Patients receive oral Venlafaxine pill and placebo powder once daily.

Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.

Outcomes

Primary Outcome Measures

Hot Flash Symptom Severity Score
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.

Secondary Outcome Measures

Quality of Life
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.

Full Information

First Posted
July 19, 2006
Last Updated
September 7, 2021
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00354432
Brief Title
Soy Protein/Effexor Hormone Therapy for Prostate Cancer
Official Title
Randomized Study of Soy Protein and Effexor on Vasomotor Symptoms of Men With Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Stopped by the DSMB for lack of effect per interim stopping rule.
Study Start Date
February 1, 2007 (Actual)
Primary Completion Date
August 1, 2010 (Actual)
Study Completion Date
August 1, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes, Prostate Cancer
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I - Placebo
Arm Type
Active Comparator
Arm Description
Patients receive oral placebo pill and oral placebo powder once daily.
Arm Title
Arm II - Soy
Arm Type
Active Comparator
Arm Description
Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
Arm Title
Arm III - Venlafaxine
Arm Type
Experimental
Arm Description
Patients receive oral Venlafaxine pill and placebo powder once daily.
Arm Title
Arm IV - Soy + Venlafaxine
Arm Type
Placebo Comparator
Arm Description
Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
Intervention Type
Dietary Supplement
Intervention Name(s)
oral soy protein/isoflavones powder
Other Intervention Name(s)
Protein powder, Supplement powder soy and casein 20gm, Isoflavones, Isocaloric supplement, Casein protein
Intervention Description
Soy protein powder (20gm) orally 160 mg of total isoflavones isocaloric supplement of casein protein
Intervention Type
Drug
Intervention Name(s)
Venlafaxine
Other Intervention Name(s)
Effexor XR, placebo
Intervention Description
Patients receive oral venlafaxine 75mg.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Powder
Other Intervention Name(s)
Casein
Intervention Description
Placebo powder (20gm casein protein) orally 0 mg of total isoflavones
Intervention Type
Drug
Intervention Name(s)
Placebo Pill
Other Intervention Name(s)
Sugar Pill
Intervention Description
Patients receive oral placebo pill.
Primary Outcome Measure Information:
Title
Hot Flash Symptom Severity Score
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Quality of Life
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mara Vitolins, DrPH, RD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
MBCCOP - JHS Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
MBCCOP - LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
CCOP - Beaumont
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073-6769
Country
United States
Facility Name
CCOP - Heartland Research Consortium
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
CCOP - St. Louis-Cape Girardeau
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
CCOP - Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Alamance Cancer Center at Alamance Regional Medical Center
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27216
Country
United States
Facility Name
Southeastern Medical Oncology Center - Goldsboro
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Caldwell Memorial Hospital
City
Lenoir
State/Province
North Carolina
ZIP/Postal Code
28645
Country
United States
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States
Facility Name
Wake Forest University CCOP Research Base
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cancer Centers of the Carolinas - Easley
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
CCOP - St. Vincent Hospital Cancer Center, Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24081940
Citation
Vitolins MZ, Griffin L, Tomlinson WV, Vuky J, Adams PT, Moose D, Frizzell B, Lesser GJ, Naughton M, Radford JE Jr, Shaw EG. Randomized trial to assess the impact of venlafaxine and soy protein on hot flashes and quality of life in men with prostate cancer. J Clin Oncol. 2013 Nov 10;31(32):4092-8. doi: 10.1200/JCO.2012.48.1432. Epub 2013 Sep 30.
Results Reference
derived

Learn more about this trial

Soy Protein/Effexor Hormone Therapy for Prostate Cancer

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