Randomized Study of Soy Protein and Effexor on Vasomotor Symptoms in Men with Prostate Cancer Mara V

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Randomized Study of Soy Protein and Effexor
onVasomotor Symptoms in Men with Prostate
Cancer Mara Vitolins, DrPH, MPH, RDWake Forest
University Health Sciences(336)
716-2886mvitolin_at_wfubmc.edu
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CCWFU CCOP Research Base Cancer Control Studies-
97405

• Phase III (2 by 2 factorial design)
• Endpoints
• Frequency and severity of hot flashes in men
  currently undergoing hormonal manipulation for
  treatment or control of prostate cancer
• Health related quality of life

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Background

• Sudden withdrawal of sex steroids as a result of
  orchiectomy and other androgen ablative therapies
  in men with prostate cancer can lead to
  troublesome vasomotor symptoms such as hot
  flashes and profuse sweating.
• These vasomotor symptoms have been shown to
  greatly affect quality of life in men who have
  undergone androgen deprivation therapy (Charig et
  al, 1989).

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Why test venalfaxine and soy protein?

• Venalfaxine is an oral antidepressant agent that
  inhibits serotonin and norephinephrine uptake.
• Isoflavones in soy are structurally similar to
  estradiol but have both estrogenic and
  antiestrogenic properties. They have been
  reported to bind to estrogen receptors.

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Combination therapy?

• Although the individual effects of venlafaxine
  and soy isoflavones may not be as powerful as the
  effects reported for hormone therapy perhaps
  taking both therapies concomitantly will provide
  additional symptom relief?

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CCWFU CCOP Research Base Cancer Control Studies

• Arm A
• Soy protein 50 g (100 mg isoflavones) and Placebo
  pill
• Arm B
• Casein protein 50 g (No isoflavones) and Effexor
  75 mg
• Arm C
• Soy protein 50 g (100 mg isoflavones) and Effexor
  75 mg
• Arm D
• Casein protein 50 g (No isoflavones) and Placebo
  pill

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CCWFU CCOP Research Base Cancer Control
Recruit, prescreen, and consent
Determine eligibility
7 days symptom recording
Baseline Assessment
Ineligibles Refusals
Soy protein and Placebo pill
Close out visit (12 weeks)
Interim contacts (Weeks 2, 4, 8)
N166
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Status Actively recruiting

• ACCRUAL
• Total as of 08/06/08 38
• Expected monthly accrual 7.0
• Average monthly accrual 2.4
• Last 6 months average 1.2

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Accrual by institution

• WFUSM 5
• SCCC 8
• RBUPS 11
• RBILL 2
• RBNICRC 4
• RBMICH 6
• RBMO 1
• RBDEL 1

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We need 128 more participants!YOUR EFFORTS TO
IDENTIFY AND RANDOMIZE PARTICIPANTS ARE GREATLY
APPRECIATED