Soy Protein/Effexor Hormone Therapy for Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00354432
• Other study ID #: REBAcccwfu97405
• Secondary ID: U10CA081851
• Status: Terminated
• Phase: Phase 3
• Start date: February 1, 2007
• Est. completion date: August 1, 2010

Study information

• Verified date: September 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: August 1, 2010
• Est. primary completion date: August 1, 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hot Flashes
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• oral soy protein/isoflavones powder
Soy protein powder (20gm) orally 160 mg of total isoflavones isocaloric supplement of casein protein

Drug:
• Venlafaxine
Patients receive oral venlafaxine 75mg.

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

Drug:
• Placebo Pill
Patients receive oral placebo pill.

Locations

Country	Name	City	State
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Alamance Cancer Center at Alamance Regional Medical Center	Burlington	North Carolina
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	MBCCOP - JHS Hospital of Cook County	Chicago	Illinois
United States	CCOP - Central Illinois	Decatur	Illinois
United States	Southeastern Medical Oncology Center - Goldsboro	Goldsboro	North Carolina
United States	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin
United States	Cancer Centers of the Carolinas - Easley	Greenville	South Carolina
United States	Caldwell Memorial Hospital	Lenoir	North Carolina
United States	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	CCOP - Beaumont	Royal Oak	Michigan
United States	CCOP - Heartland Research Consortium	Saint Louis	Missouri
United States	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri
United States	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Wake Forest University CCOP Research Base	Winston-Salem	North Carolina
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 weeks