Randomized Study of Soy Protein and Effexor on Vasomotor Symptoms of Men With Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 120
- 试验地点
- 20
- 主要终点
- Hot Flash Symptom Severity Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
- •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)
排除标准
- •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
研究组 & 干预措施
Arm I - Placebo
Patients receive oral placebo pill and oral placebo powder once daily.
干预措施: Placebo Powder (Dietary Supplement)
Arm I - Placebo
Patients receive oral placebo pill and oral placebo powder once daily.
干预措施: Placebo Pill (Drug)
Arm II - Soy
Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
干预措施: oral soy protein/isoflavones powder (Dietary Supplement)
Arm II - Soy
Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
干预措施: Placebo Pill (Drug)
Arm III - Venlafaxine
Patients receive oral Venlafaxine pill and placebo powder once daily.
干预措施: Venlafaxine (Drug)
Arm III - Venlafaxine
Patients receive oral Venlafaxine pill and placebo powder once daily.
干预措施: Placebo Powder (Dietary Supplement)
Arm IV - Soy + Venlafaxine
Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
干预措施: oral soy protein/isoflavones powder (Dietary Supplement)
Arm IV - Soy + Venlafaxine
Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
干预措施: Venlafaxine (Drug)
结局指标
主要结局
Hot Flash Symptom Severity Score
时间窗: 12 weeks
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.
次要结局
- Quality of Life(12 weeks)