CompletedNot Applicable

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

United States19 participantsStarted 2018-02-19

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

number of patients that complete the study

Timeframe: 2 years

Trial details

NCT IDNCT03285152

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-24

View on ClinicalTrials.gov More Endometrial Cancer trials