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Soy Protein/Effexor Hormone Therapy for Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00354432
Recruitment Status : Terminated (Stopped by the DSMB for lack of effect per interim stopping rule.)
First Posted : July 20, 2006
Results First Posted : May 18, 2017
Last Update Posted : December 21, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.


Condition or disease Intervention/treatment Phase
Hot Flashes Prostate Cancer Dietary Supplement: oral soy protein/isoflavones powder Drug: Venlafaxine Dietary Supplement: Placebo Powder Drug: Placebo Pill Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Study of Soy Protein and Effexor on Vasomotor Symptoms of Men With Prostate Cancer
Study Start Date : February 2007
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: Casein

Drug: Placebo Pill
Patients receive oral placebo pill.
Other Name: Sugar Pill

Active Comparator: Arm II - Soy
Patients receive oral placebo pill and oral 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: Placebo Pill
Patients receive oral placebo pill.
Other Name: Sugar Pill

Experimental: Arm III - Venlafaxine
Patients receive oral Venlafaxine pill and placebo powder once daily.
Drug: Venlafaxine
Patients receive oral venlafaxine 75mg.
Other Names:
  • Effexor XR
  • placebo

Dietary Supplement: Placebo Powder
Placebo powder (20gm casein protein) orally 0 mg of total isoflavones
Other Name: Casein

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:
  • Effexor XR
  • placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354432


Locations
Show Show 20 study locations
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Study Chair: Mara Vitolins, DrPH, RD Wake Forest University Health Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00354432    
Other Study ID Numbers: REBAcccwfu97405
U10CA081851 ( U.S. NIH Grant/Contract )
First Posted: July 20, 2006    Key Record Dates
Results First Posted: May 18, 2017
Last Update Posted: December 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
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:
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Prostatic Neoplasms
Hot Flashes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Venlafaxine Hydrochloride
Caseins
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Chelating Agents
Sequestering Agents