Ketogenic Diet for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen byVicky Makker, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test any good and bad effects of an experimental diet, called a ketogenic diet, in endometrial cancer. A ketogenic diet is one that 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. Ketosis is when the body does not have enough sugar for energy so it burns stored fats which create acids called ketones, which can be used for energy. Researchers hope to learn whether or not a ketogenic diet is well-tolerated and safe to eat before surgery in endometrial cancer patients.

Research Team

Vicky Makker, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for overweight or obese adults diagnosed with endometrial cancer who are scheduled for surgery and have not had previous treatments like chemotherapy. They must be in good health with proper organ function, no history of malabsorption, heart failure, significant infections, or conditions affecting drug absorption. Participants cannot be on certain diets or weight loss plans recently and should not have dietary restrictions that the nutrition team can't accommodate.

Inclusion Criteria

My cancer is between stage I and IVA.

AST and ALT ≤ 3.0x ULN

Total bilirubin≤1.5x the upper limit of normal (ULN)

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Exclusion Criteria

I cannot or do not want to swallow pills.

Patients with a QTc interval of >450 msec on screening electrocardiogram (ECG) for men or >470 msec for women.

Known selenium deficiency

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Treatment Details

Interventions

Ketogenic Diet (Behavioural Intervention)

Trial OverviewThe study compares a ketogenic diet (very low in carbohydrates to induce ketosis) against a standard diet to see if it's safe and tolerable before surgery for endometrial cancer patients. The goal is to understand whether burning fats instead of sugars affects the treatment outcome.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Ketogenic Diet (KD)Experimental Treatment1 Intervention

The KD cohort will receive a rotating 7 day meal plan prepared by the Clinical Translational Science Center (CTSC) at Weill Cornell Medical Center (WCMC) with weekly food pick-up. The meal plan will provide a 3:1 fat to net carbohydrate ratio and calories for weight maintenance (30kcals /kg for a BMI\< 30kg/ m2 and 25 kcal/kg for a BMI.30 kg/ m2.

Group II: Standard Diet (SD)Active Control1 Intervention

Patients randomized to the SD group will consume their normal diet plan. They will meet with the dietitian from the CTSC at WCMC weekly and receive standard nutritional counseling from the CTSC. Average intake will be documented through analyzing a 3 day intake pre and post the 4 week period.