Clinical trial NCT00354432
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
Sponsor: Wake Forest University Health Sciences
Start date: 2007-02-01; Completion date: 2010-08-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

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.

Arms: arm 1: Patients receive oral placebo pill and oral placebo powder once daily. arm 2: Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily. arm 3: Patients receive oral Venlafaxine pill and placebo powder once daily. arm 4: Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
Interventions: intervention 1: oral soy protein/isoflavones powder intervention 2: Venlafaxine intervention 3: Placebo Powder intervention 4: Placebo Pill
Intervention descriptions: intervention 1: Soy protein powder (20gm) orally 160 mg of total isoflavones isocaloric supplement of casein protein intervention 2: Patients receive oral venlafaxine 75mg. intervention 3: Placebo powder (20gm casein protein) orally 0 mg of total isoflavones intervention 4: Patients receive oral placebo pill.

Protocol documents: