A Clinical Trial of the Action of Isoflavones in Breast Neoplasia: Administration Prior to Mastectomy or Lumpectomy-A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 7
- 主要终点
- Occurrence of Soy Protein Isolate Effect
研究概览
简要总结
RATIONALE: Eating a diet rich in soy foods may slow the progression of some types of cancer. Isoflavones are compounds found in soy food that may slow the growth of breast cancer cells and prevent further development of breast cancer.
PURPOSE: Randomized pilot trial to study the effectiveness of isoflavones in preventing further development of breast cancer in women who are planning to undergo mastectomy or lumpectomy.
详细描述
OBJECTIVES:
- Determine the effect of soy protein isolate (isoflavones) on modulation of intermediate endpoint biomarkers (such as cell proliferation, apoptosis, and steroid hormones) in women planning to undergo mastectomy or lumpectomy for breast cancer.
- Determine the effect of soy protein isolate on serum isoflavone levels in these patients.
- Correlate changes in serum isoflavones with changes in cell proliferation, apoptosis, and hormonal levels in patients treated with this therapy.
- Correlate the changes in cell proliferation and apoptosis with hormonal markers in patients treated with this therapy.
OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are stratified according to the phase of the menstrual cycle at time of biopsy and time of surgery (follicular phase [i.e., during first 7 days of menstrual cycle] vs luteal phase [i.e., after day 7 of the menstrual cycle]). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral soy protein isolate twice daily and oral multivitamins once daily.
- Arm II:Patients receive oral placebo twice daily and oral multivitamins once daily.
In both arms, treatment continues for 2-4 weeks depending on time from study entry to planned surgical procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Undergoing breast biopsy for any stage breast cancer
- •No excisional biopsy
- •At least one core biopsy block must contain carcinoma
- •Definitive surgery (mastectomy or lumpectomy) planned for 2-4 weeks after registration to this study
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Premenopausal
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •No known prior hepatic disease
- •No known prior renal disease
- •Not pregnant or nursing
- •Fertile patients must use effective non-hormonal contraception
- •No other prior malignancy except nonmelanoma skin cancer
- •No known prior thyroid disease
- •No adherence to vegan diet or other special dietary requirements that would preclude study participation
- •No allergy to study agent
- •No obesity (body mass index greater than 32)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •No concurrent birth control pills or other hormonal therapy
- •No concurrent thyroid hormone replacement medications
- •Radiotherapy:
- •Not specified
- •See Disease Characteristics
- •More than 30 days since prior antibiotics
- •More than 4 weeks since prior soy products
- •No routine consumption of greater than 40 mg of soy/day
- •No other concurrent nutritional supplements, including modular supplements of other isoflavones
排除标准
- 未提供
研究组 & 干预措施
Soy protein isolate
Administration Prior to Mastectomy or Lumpectomy.
Patients receive oral soy protein isolate twice daily and oral multivitamins once daily.
Treatment continues for 2-4 weeks depending on time from study entry to planned surgical procedure.
干预措施: Soy protein isolate (Dietary Supplement)
Placebo
Administration Prior to Mastectomy or Lumpectomy.
Patients receive oral placebo twice daily and oral multivitamins once daily.
Treatment continues for 2-4 weeks depending on time from study entry to planned surgical procedure.
干预措施: Placebo (Other)
结局指标
主要结局
Occurrence of Soy Protein Isolate Effect
时间窗: 1 Year
Determine the effect of soy protein isolate (isoflavones) on modulation of intermediate endpoint biomarkers (such as cell proliferation, apoptosis, and steroid hormones) in women planning to undergo mastectomy or lumpectomy for breast cancer.
次要结局
- Occurrence of Effect on Serum Isoflavone Levels(1 Year)