NCT00100893已完成1 期
A Phase I Prevention Trial of ACTIVIN Grape Seed Extract as an Aromatase Inhibitor In Healthy Postmenopausal Women at Risk for Breast Cancer
City of Hope Medical Center2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2005年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Estrogen suppression as measured by serum estradiol, estrone, estrone sulfate, and sex hormone binding globulin
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of IH636 grape seed extract may prevent breast cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of IH636 grape seed extract in preventing breast cancer in postmenopausal women at risk of developing breast cancer.
详细描述
OBJECTIVES:
- Determine the efficacy of IH636 grape seed proanthocyanidin extract, in terms of suppression of estrogen biosynthesis, in healthy post-menopausal women at high risk of developing breast cancer.
- Determine the safety and tolerability of this dietary supplement, in terms of symptoms and changes in markers of bone and lipid metabolism and in markers of nonspecific adrenal suppression, in these participants.
- Determine, preliminarily, an optimum biologic dose of this dietary supplement, as defined by suppression of serum estradiol, in these participants.
- Determine a minimum duration of use of this dietary supplement to achieve aromatase inhibition in these participants.
OUTLINE: This is a pilot, dose-finding, placebo-controlled study.
Participants receive oral placebo once or twice daily on days -14 to 0. Participants then receive oral IH636 grape seed proanthocyanidin extract once or twice daily on days 1-85. Treatment continues in the absence of toxicity.
Cohorts of 6 participants receive one of four dose levels of IH636 grape seed proanthocyanidin extract up to an established safe dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •DISEASE CHARACTERISTICS:
- •At risk of developing breast cancer
- •No history of breast cancer or ductal carcinoma in situ
- •PATIENT CHARACTERISTICS:
- •Menopausal status
- •Postmenopausal, defined by 1 of the following criteria:
- •No spontaneous menses for ≥ 12 months
- •Prior bilateral oophorectomy
- •Prior hysterectomy with follicle-stimulating hormone within menopausal range
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Hemoglobin ≥ 9.0 g/dL
- •Platelet count ≥ 100,000/mm^3
- •WBC ≥ 3,500/mm^3
- •Absolute granulocyte count ≥ 1,500/mm^3
- •No coagulation disorders
- •SGOT and SGPT ≤ 2 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Cardiovascular
- •No major illness of the cardiovascular system
- •No major illness of the respiratory system
- •No history of other invasive cancer within the past 5 years except squamous cell or basal cell skin cancer
- •No major systemic infection
- •No Cushing's syndrome or adrenal insufficiency
- •No osteoporosis, defined as a bone mineral density T-score ≥ -2.5 on dual-energy x-ray absorptiometry scan (calcium and/or cholecalciferol [vitamin D] supplementation AND/OR bisphosphonate therapy allowed provided participant is on a stable dose during study participation)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •More than 3 months since prior hormone-modifying medications, including any of the following:
- •Oral contraceptives
- •Hormone replacement therapy
- •Selective estrogen receptor modifiers
- •Aromatase inhibitors
- •Gonadotropin-releasing hormone modifiers
- •Concurrent dehydroepiandrosterone (DHEA) allowed, provided dose remains constant during study participation
- •Radiotherapy
- •Not specified
- •Not specified
- •No red wine, red grapes, or white button mushrooms directly before or during study treatment
- •White and seedless grapes allowed
- •No other concurrent therapy
排除标准
- 未提供
结局指标
主要结局
Estrogen suppression as measured by serum estradiol, estrone, estrone sulfate, and sex hormone binding globulin
时间窗: at 1, 2, 4, 8, and 12 weeks
次要结局
- Bone metabolic effects as measured by bone-specific alkaline phosphatase and N-telopeptides(at 12 weeks)
- Insulin regulatory effects as measured by insulin-like growth factor 1 (IGF1) and insulin-like growth factor-binding protein 3 (IGFBP3)(at 12 weeks)
- Pharmacokinetics as measured by procyanidins(before and after first dose and then at 1, 2, 4, 8, and 12 weeks)
- Androgenic effects as measured by serum testosterone, androstenedione, dehydroepiandrosterone (DHEA), and dehydroepiandrosterone sulfate (DHEAS)(at 1, 2, 4, 8, and 12 weeks)
- Lipid effects as measured by total cholesterol, LDL, HDL, and triglycerides(at 12 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Selenium in Preventing Cancer Recurrence in Patients With Bladder CancerBladder CancerNCT00729287KU Leuven276
已完成
2 期
Phase II A Trial of Curcumin Among Patients With Prevalent Subclinical Neoplastic Lesions (Aberrant Crypt Foci)Healthy, no Evidence of DiseaseTobacco Use DisorderNCT00365209National Cancer Institute (NCI)44
已完成
3 期
Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy ParticipantsPrecancerous ConditionCervical CancerNCT00128661GlaxoSmithKline7,466
已完成
1 期
Celecoxib in Preventing Colorectal Cancer in Young Patients With a Genetic Predisposition for Familial Adenomatous PolyposisPrecancerous ConditionColorectal CancerNCT00685568M.D. Anderson Cancer Center22
已完成
1 期
UMCC 2003-064 Resveratrol in Preventing Cancer in Healthy ParticipantsUnspecified Adult Solid Tumor, Protocol SpecificNCT00098969National Cancer Institute (NCI)40