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Could a Low-Carb diet help fight endometrial cancer?

NCT ID NCT03285152

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 30, 2026 · Updated 2 times

Summary

This study looks at whether a ketogenic diet—a very low-carbohydrate diet that forces the body to burn fat for energy—is safe and tolerable for overweight or obese women with newly diagnosed endometrial cancer before they have surgery. Nineteen participants will either follow the special diet or receive standard dietary counseling. The main goal is to see how many patients can complete the diet, not to measure cancer outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ketogenic diet
What this could lead to
If it works, this could point toward a dietary approach to help manage endometrial cancer before surgery.
What could go wrong
This is a very small, early feasibility study with only 19 participants, so results may not apply to everyone. The diet may be hard to follow or cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

19 people

The number who actually took part.

Started

Feb 2018

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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. * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (Consent and Follow up)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

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

    Commack, New York, 11725, United States

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

    Middletown, New Jersey, 07748, United States

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

    Rockville Centre, New York, 11570, United States

  • Memorial Sloan Kettering Westchester (Consent & Follow Up)

    Harrison, New York, 10604, United States

  • New York Weill Cornell Cancer Center at Cornell University

    New York, New York, 10021, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.