Ketogenic Diet for Endometrial Cancer

Not currently recruiting at 10 trial locations

Overseen By Nadeem 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of a ketogenic diet on patients with endometrial cancer. The ketogenic diet is low in carbs and aims to induce ketosis, where the body burns fat instead of sugar for energy. Researchers aim to determine if this diet is safe and well-tolerated by patients before surgery. Suitable candidates for this trial include those diagnosed with endometrial cancer, scheduled for surgery, and who have not yet received other cancer treatments.

As an unphased trial, this study offers patients the chance to contribute to groundbreaking research on dietary impacts in cancer care.

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 prior data suggests that this diet is safe for endometrial cancer patients?

Research has shown that ketogenic diets, low in carbohydrates and high in fats, are generally safe and well-tolerated by cancer patients. Some studies suggest these diets might stabilize or improve the disease in certain cases. However, concerns about possible risks exist. For instance, one study indicated that a ketogenic diet could increase the risk of cancer spreading in some situations.

Overall, while many patients manage the diet well, it is crucial to follow it carefully and under medical supervision, especially during cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for endometrial cancer, which often involve surgery, radiation, or chemotherapy, the ketogenic diet offers a non-invasive approach. This diet is unique because it shifts the body's energy source from carbohydrates to fats, potentially starving cancer cells that rely on glucose. Researchers are excited about this treatment because it offers a novel mechanism of action that could complement traditional therapies and might improve outcomes by creating a less hospitable environment for cancer growth.

What evidence suggests that a ketogenic diet might be an effective treatment for endometrial cancer?

This trial will compare the effects of a ketogenic diet with a standard diet for women with endometrial cancer. Research has shown that a ketogenic diet might help cancer patients by reducing body fat, maintaining muscle, and lowering insulin levels. Some studies suggest it might slow tumor growth, but there is concern it could also increase the risk of cancer spreading. Most research indicates that the ketogenic diet can enhance the effectiveness of cancer treatments. However, these benefits must be weighed against the potential risks. ^{1 3 6 7 8}

Who Is on the Research Team?

Vicky Makker, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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)

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Ketogenic Diet

Trial Overview The 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.

How Is the Trial Designed?

Group I: Ketogenic Diet (KD) Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

New York University

Collaborator

Trials

249

Recruited

229,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12313497/

Impact of ketogenic diets on cancer patient outcomes The ketogenic diet was found to improve cancer patients' outcomes more effectively than non-ketogenic diets. Notably, C-reactive protein levels ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8496516/

A Ketogenic Diet Reduces Central Obesity and Serum ... In women with ovarian or endometrial cancer, a KD results in selective loss of fat mass and retention of lean mass. Visceral fat mass and fasting serum insulin ...

3. cancer.columbia.edu cancer.columbia.edu/news/study-finds-keto-diet-could-contribute-cancer-metastasis

New Study Links the Keto Diet to Cancer Metastasis “We did indeed see that the ketogenic diet suppressed tumor growth — but we also saw, surprisingly, that it promoted tumor metastasis,” says Gu.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0007455125003327

Prospects of the therapeutic approaches of ketogenic diet ... Nearly almost of the studies found that there was a potential role of KD in the prognosis of cancer treatment. The current review suggests that cancer patients ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2212877819304272

Ketogenic diet in the treatment of cancer – Where do we ... The ketogenic diet, a high-fat, low-carbohydrate diet with adequate amounts of protein, appears to sensitize most cancers to standard treatment.

6. sciencedirect.com sciencedirect.com/science/article/pii/S002231662216390X

A Ketogenic Diet Reduces Central Obesity and Serum ... The limited evidence available suggests that KDs are safe, feasible, and may contribute to improved or stable disease status among cancer patients (23, 24, 25, ...

7. nature.com nature.com/articles/s41598-025-06675-6

A phase 1 safety and feasibility trial of a ketogenic diet plus ... This phase 1 trial demonstrates that KD is safe and feasible for GBM patients receiving SOC, may improve outcomes, and provides a foundation for an NCI-funded ...

8. fredhutch.org fredhutch.org/en/news/center-news/2019/10/keto-fat-cancer-its-complicated.html

Keto, fat and cancer: It's complicated Cancer patients need to be especially careful that they don't keto themselves into a corner. Some people may do well on a high-fat keto diet; ...