Full TitleIIT: A Feasibility Study Evaluating Metabolomic and Tissue Effects of Ketogenic Diet in Newly Diagnosed Overweight or Obese Endometrial Cancer Patients
The purpose of this study is to assess the effects of a ketogenic diet in overweight and obese women scheduled to have surgery for endometrial cancer. A ketogenic diet is very low in carbohydrates (simple and complex sugars). The goal of this diet is for the body to go into a state of ketosis, which causes the body to burn stored fats for energy. Researchers will evaluate the effects that this type of diet has on endometrial cancer and on patients’ hormone levels.
In most patients with endometrial cancer, there are signals in the body that are abnormally regulated. These signals can cause increased inflammation, elevated cholesterol, and higher levels of insulin and blood sugar. Researchers believe that a ketogenic diet may lower inflammation, bad cholesterol, insulin, and blood sugar, which may help to control signals in the body that could shrink endometrial cancer.
Participants in this study will have blood and urine tests in addition to their usual treatment, and will have a small sample of endometrial tissue from their surgery examined for certain genetic and metabolic markers. They will be randomly assigned to follow the ketogenic diet or their regular diet for four weeks before endometrial cancer surgery. Women in the ketogenic diet group will need to come to Weill Cornell Medical College on the Upper East Side of Manhattan to pick up their food each week.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must be overweight or obese women with newly diagnosed endometrial cancer that has not yet been treated.
- Women with diabetes, gout, and seizure disorders may not participate.
- Patients may not have participated in a weight loss plan within 4 weeks of starting the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for women age 18 and older.
For more information about this study and to inquire about eligibility, please contact Dr. Vicky Makker at 646-888-4224.