Soy Protein/Isoflavones and Venlafaxine in Treating Hot Flashes in Patients Receiving Hormone Therapy for Prostate Cancer

Official Title: “Randomized Study of Soy Protein and Effexor on Vasomotor Symptoms of Men With Prostate Cancer”

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.

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.

Intervention(s) in this Clinical Trial

• Dietary Supplement: soy isoflavones
  • Given orally
• Dietary Supplement: soy protein isolate
  • Given orally
• Drug: venlafaxine
  • Given orally
• Other: placebo
  • Given orally

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm I
  • Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
• Active Comparator: Arm II
  • Patients receive oral venlafaxine and oral placebo powder once daily.
• Experimental: Arm III
  • Patients receive oral venlafaxine and oral soy protein/isoflavones powder once daily.
• Placebo Comparator: Arm IV
  • Patients receive oral placebo pill and oral placebo powder once daily.

Primary Measures

• Percentage change in the hot flash symptom severity score from baseline to 12 weeks
  • Safety Issue?: No

Secondary Measures

• Quality of life as assessed by FACT-P at baseline and at 12 weeks of treatment
  • Safety Issue?: No
• Adherence to treatment regimens
  • Safety Issue?: No

DISEASE CHARACTERISTICS:

• Histologically confirmed prostate cancer
• Any stage disease allowed
• Undergoing or underwent androgen deprivation for treatment or control of prostate cancer including any of the following:
• Bilateral orchiectomy
• Luteinizing hormone-releasing hormone (LHRH) agonist therapy (e.g., leuprolide, goserelin, bicalutamide, flutamide, or similar agents) with or without antiandrogen therapy
• Chemotherapy
• Radiotherapy (patients may undergo concurrent radiotherapy to the prostate, prostate and seminal vesicles, and/or pelvis)
• Seed implants allowed
• Hot flash frequency ≥ 4 per day, as defined by sweating, flushing, sensation of warmth, night sweats
• Hot flashes must be moderated (grade 2) or severe (grade 3)
• Patient reports overall hot flash severity as moderate to severe

PATIENT CHARACTERISTICS:

• Life expectancy ≥ 9 months
• Bilirubin < 2 mg/dL
• AST ≤ 2 times normal
• Must have a telephone
• No allergies to soy or dairy products
• No uncontrolled hypertension (i.e., BP 160/90 mm Hg) or American Heart Association functional capacity ≥ class I
• No history of mania, hypomania, bipolar disorder, or anorexia nervosa
• No history of seizures
• No history of hepatic dysfunction
• No history of intolerance to venlafaxine
• No history of seizure disorder

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• More than 14 days since prior venlafaxine, monoamine oxidase inhibitor (MAOI), selective serotonin reuptake inhibitor (SSRI), or selective norepinephrine reuptake inhibitor (SNRI)
• Prior and concurrent stable regimen of soy foods, or soy based supplements allowed
• Concurrent stable regimen of herbal supplements for hot flashes allowed
• No concurrent chemotherapy, radiotherapy, or surgery
• No concurrent estrogen, progestational agents, corticosteroids, androgens, or other medications (such as clonidine or bellamine) directed at alleviating hot flashes
• No concurrent SSRIs, SNRIs, MAOIs, or linezolide
• No concurrent medication to relieve hot flashes
• No other concurrent antidepressant therapy

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Wake Forest University Other

Overall Clinical Trial Officials and Contacts

Mara Vitolins, DrPH, RD Study Chair Wake Forest University  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00354432

Study ID Number: CDR0000489382

ClinicalTrials.gov Identifier: NCT00354432

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database