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

NCT03285152 | Active Not Recruiting

• 1 other identifier: 17-396
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Endometrial Cancer

Keywords

Ketogenic Diet; 17-396

Outcome Measures

Primary Outcomes (1)

• number of patients that complete the study

  2 years

Study Arms (2)

Ketogenic Diet (KD)

EXPERIMENTAL

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.

Other: Ketogenic Diet (KD)

Standard Diet (SD)

ACTIVE COMPARATOR

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.

Other: Standard Diet (SD)

Interventions

Ketogenic Diet (KD) OTHER

specially-formulated very low carbohydrate meals (KD)

Ketogenic Diet (KD)

Standard Diet (SD) OTHER

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

Standard Diet (SD)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Endometrial Cancer Patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Weill Medical College of Cornell University: collaborator
• New York University: collaborator

Study Sites (8)

Memorial Sloan Kettering Basking Ridge (Consent and Follow up)

Basking Ridge, New Jersey, 07920, United States

Location

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

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Consent and Follow up)

Montvale, New Jersey, 07645, United States

Location

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

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Consent & Follow Up)

Harrison, New York, 10604, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Consent and Follow-up)

Rockville Centre, New York, 11570, United States

Location

Related Publications (1)

• 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.

  PMID: 36971688 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Vicky Makker, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 15, 2017
• Study Start: February 19, 2018
• Primary Completion (Estimated): August 11, 2026
• Study Completion (Estimated): August 11, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-09

Locations

US (8)