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Ketogenic Diet for Endometrial Cancer
N/A
Waitlist Available
Led By Vicky Makker, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with stage I-IVA are eligible
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether a ketogenic diet is safe and effective in endometrial cancer patients.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects from the ketogenic diet may include digestive issues such as constipation or diarrhea, changes in blood sugar levels, possible nutrient deficiencies due to restricted food choices, fatigue from altered energy metabolism, and possibly increased risk of kidney stones.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is between stage I and IVA.
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I have been diagnosed with a specific type of endometrial cancer at MSK.
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I have not received any additional treatment for endometrial cancer after the initial surgery.
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I have agreed to surgery with a certified gynecologic surgeon.
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I can understand and communicate in English, or have someone who can do this for me.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
number of patients that complete the study
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Ketogenic Diet (KD)Experimental Treatment1 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 Control1 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.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,603 Total Patients Enrolled
19 Trials studying Endometrial Cancer
4,461 Patients Enrolled for Endometrial Cancer
Weill Medical College of Cornell UniversityOTHER
1,054 Previous Clinical Trials
1,316,509 Total Patients Enrolled
1 Trials studying Endometrial Cancer
1,120 Patients Enrolled for Endometrial Cancer
Vicky Makker, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
171 Total Patients Enrolled
3 Trials studying Endometrial Cancer
131 Patients Enrolled for Endometrial Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is between stage I and IVA.I cannot or do not want to swallow pills.You have a body mass index (BMI) higher than 23 kg/m2.I do not have an active infection needing antibiotics, except for a simple UTI.If you have any other health condition or abnormal test results that may make it unsafe for you to take the experimental drug or could affect the study results, you may not be able to participate.I do not have any severe illnesses that are not under control.I have had kidney stones in the past.I have severe constipation or a condition where worsening constipation would be harmful.I have not received any additional treatment for endometrial cancer after the initial surgery.My liver is functioning well, as confirmed by recent tests.My cancer can be measured and is not just in my brain.I don't need dexamethasone for brain-related issues.I have agreed to surgery with a certified gynecologic surgeon.I can understand and communicate in English, or have someone who can do this for me.I have been diagnosed with a specific type of endometrial cancer at MSK.I do not have cancer in the lining of my brain and spinal cord.I have diabetes and am taking medication for it.My brain scans showed no worsening after treatment and no new issues before my screening.I am fully active or restricted in physically strenuous activity but can do light work.I agree to let my tumor samples be used for research.You have a severe allergy or intolerance to eggs, gluten, or milk protein, and the nutrition team cannot make special accommodations for your dietary needs.I have a history of gout.I am 18 years old or older.My kidney function tests are within normal ranges.My kidney function, measured by creatinine levels or clearance, is within the required range.I have a significant history of liver problems or currently abuse alcohol.I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study.I have treated brain metastases and no longer need medication for symptoms.I have a condition that affects how my body absorbs nutrients.I have moderate to severe heart failure.I have never had bleeding in my brain or spinal cord.I am HIV positive.I have been diagnosed with a seizure disorder.I am currently on a daily dose of 10 mg or more of prednisone or its equivalent.I have untreated or poorly controlled acid reflux.I have not had a heart attack or unstable chest pain in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Diet (SD)
- Group 2: Ketogenic Diet (KD)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical experiment have any vacancies?
"The data posted on clinicaltrials.gov confirms that this medicinal research effort is no longer recruiting test subjects. Initially launched on August 11th 2017, the trial had its last update on July 29th 2022 and has since ceased recruitment activities. However, there are still 618 other medical studies actively looking for volunteers."
Answered by AI
How many venues has this experiment been deployed to?
"Currently, 10 different medical centres are offering enrolment in this clinical trial. These facilities can be found in the cities of Rockville Centre, Basking Ridge and Harrison as well as 7 other sites. Choosing to participate at a clinic close by might help reduce travel-related strain."
Answered by AI
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