The RECHARGE Low Carbohydrate Diet Trial for Metastatic Cancer

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.).

Sex

All

Minimum age

21 Years

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

• BACKGROUNDFine EJ, Miller A, Quadros EV, Sequeira JM, Feinman RD. Acetoacetate reduces growth and ATP concentration in cancer cell lines which over-express uncoupling protein 2. Cancer Cell Int. 2009 May 29;9:14. doi: 10.1186/1475-2867-9-14. PMID 19480693
• BACKGROUNDFine EJ, Segal-Isaacson CJ, Feinman R, Sparano J: Carbohydrate restriction in patients with advanced cancer: a protocol to assess safety and feasibility with an accompanying hypothesis. Commun Oncol 2008;5:22-26