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A Feasibility Study Evaluating Metabolomic and Tissue Effects of Ketogenic Diet in Newly Diagnosed Overweight or Obese Endometrial Cancer Patients

Clinical Trial Details

This clinical trial is for women aged 18 or older with a diagnosis of endometrial carcinoma on a tissue sample (biopsy) obtained at Memorial Sloan Kettering (MSK) or Weill Cornell Medicine (WCM).

Endometrial cancer is the second leading cause of death from gynecologic cancer with an estimated 10,470 women dying in the United States annually. Obesity is one of the strongest risk factors for endometrial cancer and accounts for about 50% of the cases in Europe and in the USA. Obese women (BMI >30 kg/m2) have a threefold increased risk of developing endometrial cancer compared to normal weight women. Furthermore, obesity has been associated with increased mortality in endometrial cancer.

The purpose of this study is to test any good and bad effects of an experimental diet, called a ketogenic diet, in endometrial cancer. Patients can be randomized to one of two different arms: they can either receive a standard diet, or a ketogenic diet. Randomization means that you are put into a group by chance. It is like flipping a coin.

  • Randomization arms:
    • Arm 1: Patients in the Ketogenic Diet (KD) group will receive a rotating 7-day meal plan (prepared by nutritionists at Weill Cornell) with weekly food pick-up; the diet will continue for 3-4 weeks.
    • Arm 2: Standard diet (SD) group will consume their normal diet plan. They will meet with a dietitian from Weill Cornell and also receive standard nutritional counseling; this diet will continue for 3-4 weeks. 
  • Treatment plan: Screening period is 28 days. Eligible patients will complete either a Ketogenetic or Standard diet for up to 4 weeks. All patients will then have definitive surgery. After surgery, your doctor will continue to watch you for side effects and follow your condition for 30 days.
Key Eligibility: 

• Women age 18 and older
• Confirmed newly diagnosed, previously untreated endometrial cancer
• BMI ≥ 25 kg/m2

Study contact by location

Upper East Side - Manhattan

Contact(s)

Maurice Hurd
(646) 962-6171
mah4011@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1905020075

ClinicalTrials.gov:

NCT03285152

Sponsor:

17396

Status

Open to Enrollment

Age Group

Adult

Sponsor