Soy Protein/Effexor Hormone Therapy for Prostate Cancer

NCT00354432 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: REBAcccwfu97405U10CA081851
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 20

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• Quality of Life

  12 weeks

Study Arms (4)

Arm I - Placebo

ACTIVE COMPARATOR

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

Dietary Supplement: Placebo Powder; Drug: Placebo Pill

Arm II - Soy

ACTIVE COMPARATOR

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

Dietary Supplement: oral soy protein/isoflavones powder; Drug: Placebo Pill

Arm III - Venlafaxine

EXPERIMENTAL

Patients receive oral Venlafaxine pill and placebo powder once daily.

Drug: Venlafaxine; Dietary Supplement: Placebo Powder

Arm IV - Soy + Venlafaxine

PLACEBO COMPARATOR

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

Dietary Supplement: oral soy protein/isoflavones powder; Drug: Venlafaxine

Interventions

oral soy protein/isoflavones powder DIETARY_SUPPLEMENT

Soy protein powder (20gm) orally 160 mg of total isoflavones isocaloric supplement of casein protein

Also known as: Protein powder, Supplement powder soy and casein 20gm, Isoflavones, Isocaloric supplement, Casein protein

Arm II - Soy; Arm IV - Soy + Venlafaxine

Venlafaxine DRUG

Patients receive oral venlafaxine 75mg.

Also known as: Effexor XR, placebo

Arm III - Venlafaxine; Arm IV - Soy + Venlafaxine

Placebo Powder DIETARY_SUPPLEMENT

Placebo powder (20gm casein protein) orally 0 mg of total isoflavones

Also known as: Casein

Arm I - Placebo; Arm III - Venlafaxine

Placebo Pill DRUG

Patients receive oral placebo pill.

Also known as: Sugar Pill

Arm I - Placebo; Arm II - Soy

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (20)

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

MBCCOP - JHS Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

Shreveport, Louisiana, 71130-3932, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Beaumont

Royal Oak, Michigan, 48073-6769, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65804, United States

Location

CCOP - Heartland Research Consortium

St Louis, Missouri, 63131, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

Alamance Cancer Center at Alamance Regional Medical Center

Burlington, North Carolina, 27216, United States

Location

Southeastern Medical Oncology Center - Goldsboro

Goldsboro, North Carolina, 27534, United States

Location

Caldwell Memorial Hospital

Lenoir, North Carolina, 28645, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Wake Forest University CCOP Research Base

Winston-Salem, North Carolina, 27157, United States

Location

Cancer Centers of the Carolinas - Easley

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Related Publications (1)

• 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.

  PMID: 24081940 DERIVED

MeSH Terms

Conditions

Hot Flashes; Prostatic Neoplasms

Interventions

Soybean Proteins; Isoflavones; Venlafaxine Hydrochloride; Caseins; Sugars

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids; Milk Proteins; Animal Proteins, Dietary; Phosphoproteins; Carbohydrates

Limitations and Caveats

The study was stopped early by the DSMB due to a lack of effect.

Results Point of Contact

• Title: Dr. Doug Case
• Organization: Wake Forest University School of Medicine

dcase@wakehealth.edu

(336) 716-5425

Study Officials

• Mara Vitolins, DrPH, RD

  Wake Forest University Health Sciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2006
• First Posted: July 20, 2006
• Study Start: February 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 28, 2021
• Results First Posted: May 18, 2017

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)