Ovarian Cancer

Endometrial Cancer

This trial is limited to female participants, as it is a study of ovarian and endometrial cancer patients.

Participants in the usual care plus ketogenic diet group will receive usual care plus dietary counseling in accordance with a ketogenic diet such that ~5% energy comes from carbohydrate, 25% energy from protein, and 70% energy from fat for the duration of the 12 week study.

Ketogenic diet

Participants in the usual care plus AND diet group will receive usual care plus dietary counseling in accordance with the Academy of Nutrition and Dietetics guidelines in 2013 for the duration of the 12 week study.

AND diet

Targeted Disruption to Cancer Metabolism and Growth Through Dietary Macronutrient Modification

Targeted Disruption to Cancer Metabolism Through Dietary Macronutrient Modification

fasting serum concentrations of a variety of inflammatory markers

Physical and mental health functioning as assessed by the Medical outcomes Study Short Form-12 Health Survey, which produces a physical component summary and mental component summary score.

Perceived hunger assessed by a visual analog scale

Cravings for particular types foods (fats, sweets, starches) as assessed by the Food Craving Inventory

fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides

Barbara Gower

Professor

University of Alabama at Birmingham

American Institute for Cancer Research

This study is a randomized clinical trial with a parallel arm design to evaluate the effects of 12 weeks of usual care plus AND or usual care plus KD on women with ovarian and endometrial cancer.

metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen

metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen
metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy
carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy

Metformin /Carbohydrate Restricted Diet

Sex: Female, Male

Progress Free Survival (PFS) is defined as the time from the date of the first dose of treatment to the earlier of the dates of first disease progression per RECIST 1.1 or death from any cause.

Progress Free Survival

Overall survival (OS) is defined as time from date of first dose to date of death from any cause.

Overall Survival

To evaluate LKBI mutations as a potential bio-marker to predict subjects who will benefit most from metformin in combination with a carbohydrate restricted diet

Number of Participants With LKBI Mutation

Overall Study

Dr. Anish Parikh

Non-small Cell Lung Cancer Stage IIIB/IV

Non-small Cell Lung Cancer Metastatic

Nonsquamous Nonsmall Cell Neoplasm of Lung

Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy

metformin

addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy

carbohydrate restricted diet

Beth Israel Medical Center

Beth Israel Comprehensive Cancer Center

St.Luke's-Roosevelt Hospital Center

Mount Sinai Ichan School of Medicine

Metformin and Carbohydrate Restriction With Platinum Based Chemotherapy In Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NS-NSCLC)

Metformin With a Carbohydrate Restricted Diet In Combination With Platinum Based Chemotherapy In Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NS-NSCLC) - METRO Study

St. Luke's-Roosevelt Hospital Center

Patients are placed on a low carbohydrate diet (<30 grams/day) for 28 days.

Cancer

Breast Cancer

Colon Cancer

Cervical Cancer

Uterine Cancer

Very low carbohydrate diet for a duration of four weeks.

Very low carbohydrate diet (approximately 20 grams per day)

The RECHARGE Trial at The Albert Einstein College of Medicine

Faculty Profile Site for Eugene Fine, Principle Investigator

ovarian neoplasms/carbohydrate

Targeted Disruption to Cancer Metabolism and Growth Through Dietary Macronutrient Modification

Metformin and Carbohydrate Restriction With Platinum Based Chemotherapy In Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NS-NSCLC)

The RECHARGE Low Carbohydrate Diet Trial for Metastatic Cancer

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