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

Korábbi kezelés

• History of diabetes and on active diabetes treatment with pharmacotherapy (oral hypoglycemics or insulin)
• History of myocardial infarction or unstable angina within 6 months prior to first study treatment.
• Need for current chronic corticosteroid therapy (≥ 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids)
• Patients of childbearing potential must have a negative pregnancy test within 11 days prior to treatment start to be eligible
• 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.
• 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.

Más betegség

• History of gout.
• Active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection)
• New York Heart Association Class II or greater congestive heart failure.
• History of malabsorption syndrome or other condition that would interfere with enteral absorption.
• Clinically significant history of liver disease, including cirrhosis and current alcohol abuse.
• Known active hepatitis infection
• Known HIV infection.
• Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
• 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
• History of nephrolithiasis or nephrolithiasis including that incidentally discovered during CT screening.
• Diagnosis of seizure disorder
• Severe constipation or condition where exacerbation of constipation is not advisable (e.g. small bowel obstruction history)
• 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

Laborértékek

• Patients with a QTc interval of \>450 msec on screening electrocardiogram (ECG) for men or \>470 msec for women.
• 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.

Egyéb

• Inability or unwillingness to swallow
• Pregnancy, lactation, or breastfeeding
• Inability to comply with study and follow-up procedures
• Known selenium deficiency
• 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

• 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.