Clinical trial NCT00354432: 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
Overall status: TERMINATED
Phase: PHASE3
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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-07-20
Enrollment: 120
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Hot Flash Symptom Severity Score
timeFrame: 12 weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Newark
country: United States
facility: CCOP - Christiana Care Health Services
state: Delaware
city: Chicago
country: United States
facility: MBCCOP - JHS Hospital of Cook County
state: Illinois
city: Decatur
country: United States
facility: CCOP - Central Illinois
state: Illinois
city: South Bend
country: United States
facility: CCOP - Northern Indiana CR Consortium
state: Indiana
city: Cedar Rapids
country: United States
facility: CCOP - Cedar Rapids Oncology Project
state: Iowa
city: New Orleans
country: United States
facility: MBCCOP - LSU Health Sciences Center
state: Louisiana
city: Shreveport
country: United States
facility: Feist-Weiller Cancer Center at Louisiana State University Health Sciences
state: Louisiana
city: Ann Arbor
country: United States
facility: CCOP - Michigan Cancer Research Consortium
state: Michigan
city: Royal Oak
country: United States
facility: CCOP - Beaumont
state: Michigan
city: Saint Louis
country: United States
facility: CCOP - Heartland Research Consortium
state: Missouri
city: Saint Louis
country: United States
facility: CCOP - St. Louis-Cape Girardeau
state: Missouri
city: Springfield
country: United States
facility: CCOP - Cancer Research for the Ozarks
state: Missouri
city: Burlington
country: United States
facility: Alamance Cancer Center at Alamance Regional Medical Center
state: North Carolina
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center - Goldsboro
state: North Carolina
city: Lenoir
country: United States
facility: Caldwell Memorial Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University CCOP Research Base
state: North Carolina
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas - Easley
state: South Carolina
city: Spartanburg
country: United States
facility: CCOP - Upstate Carolina
state: South Carolina
city: Green Bay
country: United States
facility: CCOP - St. Vincent Hospital Cancer Center, Green Bay
state: Wisconsin
Study officials:
affiliation: Wake Forest University Health Sciences
name: Mara Vitolins, DrPH, RD
role: STUDY_CHAIR
References:
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.