Pilot Feasibility Study Of A Low Carbohydrate Diet In Patients With Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in tumor FDG uptake from PET/CT imaging over a 28 period. PET is done at baseline and 28 days
研究概览
简要总结
This study is for people whose cancer:
- has resisted chemotherapy
- are taking a break from chemotherapy
- or are looking for an alternative to the toxic effects of chemotherapy
The trial is looking to see if a very low carbohydrate diet can inhibit the growth of certain cancers.
The two major goals of the RECHARGE study are to determine:
- whether a very low carbohydrate diet can help participants reduce the amount of cancer in their bodies (as measured by a PET scan at the beginning and end of the study)
- whether participants can feel well while maintaining their weight on a very low carbohydrate diet
This research study is for people with advanced cancers who decline chemotherapy or want to take a break from chemotherapy and have cancers that primarily feed on blood sugar. Examples of such cancers include metastatic breast cancer, colon cancer, cervical and uterine cancers, ovarian cancers, and many others.
The investigators' intervention consists of a 28-day diet of high protein foods such as fish, poultry, meats, eggs and cheese as well as plenty of vegetables. Participants may eat as much of the high protein foods as they wish and can eat up to two cups of vegetables per day.
Participants strictly eliminate carbohydrate-containing foods. These foods include all starches and sweets (breads, pasta, rice, potatoes, cereals, fruit, cakes, candies, soda with sugar, etc.).
详细描述
You may be eligible to participate in this one month research study if you are:
- An adult with metastatic cancer (especially breast, colon, cervical, endometrial, ovarian; others may qualify) that has resisted prior attempts to treat it with courses of chemotherapy; or if you decline chemotherapy or are looking for a break, or you seek an alternative to medicines or therapies due to toxic effects.
- Your tumor has shown up on a PET scan.
- Willing to closely follow a diet and strictly limit your carbohydrate intake.
You will not be eligible to participate if you:
- Have heart or liver condition or any other disease or condition that makes it difficult or medically hazardous (determined by your doctor) for you to follow the diet recommended for this study.
- Have kidney or kidney stone disease.
Procedures:
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •You're an adult with metastatic cancer (breast, colon; others may qualify) that has been resistant to chemotherapy or would like a break from chemotherapy.
- •Your tumor shows up on a PET or PET/CT scan.
- •You are willing to closely follow a diet which strictly limits your carbohydrate intake (sugars, starches, etc). We will help you with nutrition counseling but you must prepare your meals, or have someone help you prepare your meals.
- •You are able to come to the Albert Einstein College of Medicine in Bronx, NY for an initial evaluation appointment and weekly nutrition counseling appointments for a four-week period.
排除标准
- •Have a heart condition, liver condition or any other disease or condition that makes it difficult or medically hazardous (as determined by your doctor) for you to follow the study diet.
- •Have kidney or kidney stone disease.
- •Are too thin or have lost too much weight.
结局指标
主要结局
Change in tumor FDG uptake from PET/CT imaging over a 28 period. PET is done at baseline and 28 days
时间窗: 28 day trial
次要结局
- Safety of a very low carbohydrate diet in individuals with metastatic cancer(28 days)
研究者
Eugene Fine
Principle Investigator
Albert Einstein College of Medicine