Pilot Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in ER+, Metastatic Breast Cancer Patients Receiving Endocrine Therapy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- AGE level reduction
研究概览
简要总结
The purpose of this study is to look at the effects that the study drug (OPC) has on AGE levels in patients with ER+ metastatic breast cancer.
详细描述
AGEs are a type of metabolite, or substance, found in the food. The AGE content in food is determined by the types of food you eat and also how you prepare your food. The researchers helping conduct this study have found a potential link between AGE levels and cancer. The purpose of this study is to see if certain drug (OPC) has an effect on the AGE levels in your blood and to see if those AGE levels have an effect on your cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have ER+ breast cancer
- •Metastatic disease; protocol does allow for bone-only disease
- •Must be receiving endocrine therapy
- •Must have completed at last 2 months of current endocrine therapy prior to registration
- •Must have adequate hematologic, renal and hepatic function
- •Prior/concurrent radiation therapy is allowed
- •Prior chemotherapy is allowed, but last dose must have been at least 2 months prior to enrollment
- •May have diabetes, but must not be taking metformin
- •Must be able to swallow and retain oral medication
- •Performance status of 0-2
- •Treated stable brain metastases are allowed, as long as patient does not require steroids or anti-seizure medications
- •Must be informed of the investigational nature of this study and must have the ability to sign informed consent.
排除标准
- •Known allergy to grapes or grape seed
- •More than two prior endocrine therapy regimens for the treatment of metastatic ER+ breast cancer.
- •Concurrent use of restricted agents outlined in section 4.
- •History of alcohol abuse within 2 years of registration.
研究组 & 干预措施
OPC
During weeks 1- 12, subjects will take one OPC tablet in the morning and in the evening, about 12 hours apart.
干预措施: OPC (Drug)
结局指标
主要结局
AGE level reduction
时间窗: 85 days
The primary objective is to determine if the test agents are able to reduce AGE levels by at least 30% in th 50% or more of test subjects.
次要结局
- Correlation between AGE level and plasma IL6(85 days)
- Correlation between AGE level and leptin(85 days)
- Correlation between AGE level and changes to BMI(85 days)
- Correlation between AGE level and c-reactive protein (CRP)(85 days)
- Correlation between AGE level and sRAGE (soluble receptor for AGE)(85 days)
- Frequency of adverse events as assessed by CTCAE v. 4(85 days)
- Correlation between AGE level and A1C(85 days)
- Correlation between AGE level and quality of life(85 days)
- Correlation between AGE level and oxLDLs (low density lipoprotein)(85 days)
- Correlation between AGE level and insulin resistance (HOMA-IR)(85 days)
- Correlation between AGE level and lipids(85 days)
- Correlation between AGE level and diet(85 days)
- Correlation between AGE level and malondialdehyde (MDA)(85 days)
- Tumor response to treatment as assessed by RECIST 1.1 or MD Anderson criteria(85 days)