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19 Participants Needed

Ketogenic Diet for Endometrial Cancer

Recruiting at 10 trial locations

Overseen ByNadeem Abu-Rustum, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Oral hypoglycemics, Insulin, Corticosteroids

Disqualifiers: Diabetes, Gout, Heart failure, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on diabetes medication, you cannot participate in the trial. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the ketogenic diet as a treatment for endometrial cancer?

Some studies suggest that certain dietary patterns, like a plant-based diet, may reduce the risk of endometrial cancer, and maintaining a healthy weight is important. While the ketogenic diet is high in fat and low in carbs, which is different from a plant-based diet, it may help with weight management, which is a known factor in reducing cancer risk.¹ ² ³ ⁴ ⁵

Is the ketogenic diet safe for humans?

The ketogenic diet, which is high in fats and low in carbohydrates, has been studied for various conditions and is generally considered safe for most people. However, it may not be suitable for everyone, especially those with certain health conditions, so it's important to consult with a healthcare provider before starting it.¹ ² ³ ⁶ ⁷

How does the ketogenic diet treatment differ from other treatments for endometrial cancer?

The ketogenic diet is unique because it focuses on high fat and low carbohydrate intake, which may alter the body's metabolism and energy sources, potentially affecting cancer cell growth differently than traditional treatments. Unlike other dietary approaches that emphasize fiber and plant-based foods, the ketogenic diet's high-fat content is a distinct feature that sets it apart.¹ ² ⁵ ⁸ ⁹

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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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diet Intervention

Participants follow either a standard diet or a ketogenic diet for 4 weeks

4 weeks

Weekly visits for dietary counseling and food pick-up

Follow-up

Participants are monitored for safety and effectiveness after the diet intervention

4 weeks

Treatment Details

Interventions

Ketogenic Diet

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.