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Endometrial CancerNCT03285152

A Study of Ketogenic Diet in Newly Diagnosed Overweight or Obese Endometrial Cancer Patients

A study testing Ketogenic Diet (KD) and Standard Diet (SD) in people with Endometrial Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
Ketogenic Diet (KD) and Standard Diet (SD)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
8 sitesUnited States
Study dates
19 Feb 2018to 24 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have a diagnosis endometrial carcinoma on a tissue sample obtained at MSK (biopsy). Patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, transitional cell carcinoma, carcinosarcoma.
  • Age ≥ 18 years
  • Patients must have consented to surgery with a board-certified Gyn surgeon
  • Patients must have no had adjuvant therapy for the management of endometrial carcinoma. This includes chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy. Chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen. This also pertains to hormonal, vascular, and targeted therapy for the management of endometrial cancer.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patients with stage I-IVA are eligible
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  • Adequate hematologic defined by the following laboratory results obtained within 11 days prior to first study treatment:
  • Absolute neutrophil count (ANC) ≥1.5 k/mcl
  • Platelet count ≥ 100k/mcl
  • Hemoglobin ≥ 9.0 g/dL
  • Adequate hepatic function defined by the following laboratory results obtained within 11 days prior to first study treatment:
  • Total bilirubin≤1.5x the upper limit of normal (ULN)
  • AST and ALT ≤ 3.0x ULN
  • Albumin ≥ 3.5 g/dL
  • Adequate renal function defined by the following laboratory results obtained within 11 days prior to first study treatment:
  • ° Serum creatinine≤1.5x ULN OR creatinine clearance ≥50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation
  • HbA1c ≤ 7.9 %
  • BMI ≥ 23 kg/m2
  • Patients must agree to consent to the companion genomic profiling study MSK IRB# 12-245
  • Patients must agree to consent for their tumor samples to be used for generation of cellular research tools such as organoids
  • Willingness to travel to the CTSC at WCMC weekly
  • Patient and/or Legally Authorized Representative must have the ability to read, write, speak and understand English. Note: If patient does not have the capability to read or write in English, the patient"s preferred language should be English and the LAR will be responsible for completing all study forms on the patient's behalf.

Who cannot join

  • History of diabetes and on active diabetes treatment with pharmacotherapy (oral hypoglycemics or insulin)
  • History of gout.
  • History of myocardial infarction or unstable angina within 6 months prior to first study treatment.
  • Active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection)
  • New York Heart Association Class II or greater congestive heart failure.
  • Patients with a QTc interval of >450 msec on screening electrocardiogram (ECG) for men or >470 msec for women.
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  • History of malabsorption syndrome or other condition that would interfere with enteral absorption.
  • Inability or unwillingness to swallow
  • Clinically significant history of liver disease, including cirrhosis and current alcohol abuse.
  • Known active hepatitis infection
  • Known HIV infection.
  • Need for current chronic corticosteroid therapy (≥ 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids)
  • Pregnancy, lactation, or breastfeeding
  • Patients of childbearing potential must have a negative pregnancy test within 11 days prior to treatment start to be eligible
  • Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
  • Major surgical procedure or significant traumatic injury within 28 days prior to Day 1 or anticipation of the need for major surgery during the course of study treatment.
  • Known untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible, provided that they meet all of the following criteria:
  • Presence of measurable disease outside the CNS
  • No radiographic evidence of worsening upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study
  • No history of intracranial hemorrhage or spinal cord hemorrhage
  • No ongoing requirement for dexamethasone as therapy for CNS disease (anticonvulsants at a stable dose are allowed)
  • Absence of leptomeningeal disease
  • Inability to comply with study and follow-up procedures
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
  • History of nephrolithiasis or nephrolithiasis including that incidentally discovered during CT screening.
  • Known selenium deficiency
  • Diagnosis of seizure disorder
  • Participation in a diet (Atkins, Weight Watchers, Best Life, Nutrisystem, South Beach, Jenny Craig, Paleo Diet, Zone etc) or weight loss plan within 28 days prior to Day 1 of treatment that the investigator and/or nutritionist believes will confound results.
  • Severe constipation or condition where exacerbation of constipation is not advisable (e.g. small bowel obstruction history)
  • Planned vacation or dental work during the study phase that the investigator and/or nutritionist believes will impede the study plan
  • Vegetarian or Vegan eating habits that cannot be accommodated by the nutrition team
  • Untreated or poorly controlled gastro-esophageal reflux disease.
  • An allergy or intolerance to egg, gluten or milk protein that cannot be accommodated by the nutrition team

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Memorial Sloan Kettering Basking Ridge (Consent and Follow up)

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Cancer Center @ Commack (Consent and Follow up)

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (Consent & Follow Up)

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth (Consent and follow-up only)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen (Consent and Follow up)

    Montvale, New Jersey, 07645

  • New York Weill Cornell Cancer Center at Cornell University

    New York, New York, 10021

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau (Consent and Follow-up)

    Rockville Centre, New York, 11570

Other trials in United States

About this study

Official title: 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 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.

Being tested
Ketogenic Diet (KD), Standard Diet (SD)
Keywords
Ketogenic Diet, 17-396
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ketogenic Diet (KD)Other

    specially-formulated very low carbohydrate meals (KD)

  • Standard Diet (SD)Other

    counseling on maintaining adequate nutritional intake from a normal diet (SD)

Study groups in NCT03285152
Study groupRoleWhat they receive
Ketogenic Diet (KD)ExperimentalThe 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.
Receives: Other: Ketogenic Diet (KD)
Standard Diet (SD)Active comparatorPatients 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.
Receives: Other: Standard Diet (SD)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of patients that complete the study

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2017
  2. Study start19 Feb 2018
  3. Primary completion24 Jun 2026
  4. Study completion24 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective, MSK investigator-initiated, multi-center, randomized, pilot study of KD vs SD consumption in treatment naïve endometrial cancer patients during the presurgical window period between diagnosis and surgical staging.
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03285152
Sponsor's protocol ID
17-396
Status last verified
Jun 2026
First submitted
14 Sep 2017
Last updated
29 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Agnew H, Kitson S, Crosbie EJ. Interventions for weight reduction in obesity to improve survival in women with endometrial cancer. Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD012513. doi: 10.1002/14651858.CD012513.pub3.

    PubMed 36971688

Questions about this trial

What is this clinical trial studying?

A study testing Ketogenic Diet (KD) and Standard Diet (SD) in people with Endometrial Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of patients that complete the study (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03285152, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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