Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Insulin

Insulin, Globin Zinc

45 subjects will receive a very low carbohydrate diet between a positive breast biopsy and surgical tumor removal

20 subjects will receive a lo fat diet between a positive breast biopsy and surgical tumor removal

45 subjects will be randomized to a dietary arm consisting of a complete, prepared very low carbohydrate diet, delivered to their homes, for the interval between positive breast biopsy and surgical tumor removal

Low carbohydrate diet

20 subjects will be randomized to a dietary arm consisting of a complete, prepared low fat diet, delivered to their homes, for the interval between positive breast biopsy and surgical tumor removal.

Low fat diet

Eugene J Fine, MD

Women post breast mass biopsy with ER+or ER- cancer will be randomized to two diets--goal of 45 of them to a ketogenic insulin inhibiting diet, 20 to a low fat diet with whole grains and fruits and vegetables. The initial biopsy will be evaluated along with the surgical specimen pathology to compare changes in biomarkers, particularly of proliferation (Ki-67) and apoptosis (TUNEL).

A healthy diet has been defined in various ways. The investigators wish to compare the effects of two diets on ER positive breast cancer tissues. The diets will be administered between the time of diagnosis and the time of surgical removal. Both diets have been proposed as healthy, but differ in their composition. One constitutes a low fat diet with extra fiber, fruits and vegetable servings, while the other comprises a diet low in carbohydrate content, aiming to lower insulin secretion. Patients will be randomized to each group, with 20 assigned to the low fat arm and 45 to the low carbohydrate arm.

Comparison of Healthy Diets on Breast Cancer Markers

A Pilot Presurgical Trial of Insulin Inhibition by a Ketogenic Diet in Operable Breast Cancer

Albert Einstein College of Medicine

Professor of Radiology

Symptoms and General Pathology

Neoplasm Metastasis

Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).All participants will be assigned to a ketogenic diet. There are no randomization to other separate arms since this is a safety and feasibility study.

Ketogenic Diet

Jocelyn Tan, MD

The purpose of this study is to determine the safety and tolerability of a modified low carbohydrate diet, determine if quality of life is improved and to determine if the diet has any effect on tumor growth (size or spread) and or to determine if there is any effect on progression free survival (PFS) and overall survival (OS) of subjects enrolled in the study.

In their natural state within the body, cells normally depend on cellular respiration as the source of energy and ATP. During times of complete or partial food deprivation these cells can also rely on ketosis as an additional energy source. Tumor cells in contrast are defective in this respect, lacking in the ability to utilize ketone bodies for energy and instead are heavily dependent on glycolysis for their survival. Malignant cells depend heavily on glycolysis for energy production even in high oxygen states. If the investigators limit the supply of glucose, glycolysis would decrease and tumor cells would lose their main source of energy supply.

In addition, increased carbohydrate intake is sensed by the pancreas and results in increased insulin secretion. Insulin is important for normal growth in the body and is a potent growth factor stimulating mitosis via signal transduction and DNA synthesis. It is a potent growth factor which acts by binding to cell membrane insulin receptors and stimulates mitosis via protein kinase B/Akt- mediated signal transduction and DNA synthesis.

Insulin also has anti-apoptotic properties, meaning less tumor cell death. Increased circulating insulin levels have been associated with increasing risk of certain cancers (i.e. prostate and colon cancer), but no association with serum glucose levels (8). By limiting carbohydrate intake, the investigators might expect decreased tumor growth and increased tumor cell destruction.

Most human and mouse tumors take up more glucose than their surrounding normal tissue. By using positron emission tomography with fluoro-deoxy-glucose, FDG-PET scans can be used to detect and monitor tumor response to chemotherapy and radiation.

In this study, PET/CT scanning would be utilized to measure the amount of (at the screening visit) glucose activity within certain tumors, before and after the diet.

Primary Aim: To determine the safety and tolerability of a modified low carbohydrate diet in people with advanced cancer across different tumor types.

Hypothesi(e)s: The long term tolerability of the KD (Ketogenic Diet) has been established (Groesbeck et al., 2006). Recent studies involving human patients with brain cancer showed tolerability of the Ketogenic diet over a period as long as 19 months with minimal side effects. However the MAD (Modified Atkins Diet) long term side effects are as of yet unclear. Given the similarity of the MAD compared to the KD, and being less restrictive, the long term side effects (kidney stones, dyslipidemia, gastroesophageal reflux) of the MAD is projected to be similar, if not reduced, in comparison to the KD. Modified carbohydrate diets as well as ketogenic diets have been tolerated by people with epilepsy. It is hypothesized that the effect this diet will have on overall weight loss, hyperlipidemia, and blood glucose levels will be minimal and tolerable even by cancer patients over a prolonged period of time, up to 12 months or possibly longer. Given the tolerability of the diet in brain cancer patients, it is hypothesized that patients with other types of tumors will find this diet tolerable and safe.

Secondary Aims: To determine if quality of life is improved with the use of this diet. To determine if the diet has any effect on tumor growth (size or spread) or to determine if there is any effect on progression free survival (PFS) and overall survival (OS) of subjects enrolled in the study.

Hypothesis(e): The diet showed good tolerance in human adult patient studies wherein the diet was tolerated well up to 12 weeks in a group of diverse tumor types and up to more than 10 years in a glioma patient. It is hypothesized that cancer patients will be able to tolerate this diet at 16 weeks or more. Studies in animals as well as in tumor tissue models show slowing of tumor growth, and in some instances also showed tumor shrinkage. Human case reports and a small study of 16 patients show tumor shrinkage and stable disease while on the diet.

Ketogenic Diet in Advanced Cancer

A Low-Carbohydrate Diet for Advanced or Metastatic Cancer

Recent studies involving human patients with brain cancer showed tolerability of the Ketogenic diet over a period as long as 19 months with minimal side effects. It is hypothesized that the effect this diet will have on overall weight loss, hyperlipidemia, and blood glucose levels will be minimal and tolerable even by cancer patients over a prolonged period of time, up to 12 months or possibly longer. Serum fasting glucose, cholesterol, total, LDL, HDL and triglycerides, serum ketones in mg/dl units , weight in lbs. will be measured at designated time points. Number of patients actually tolerating the diet for at least 4 weeks or more will be recorded.

VA Pittsburgh Healthcare System

Attending Physician-Hematology/Oncology

Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).

Advanced or Metastatic Cancer

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Solid cancers or blood cancers with measurable components in advanced or metastatic stages.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Healthy Diets on Breast Cancer Markers	NCT02744079	Breast Neoplasm...	Low carbohydrat... Low fat diet	21 Years -	Albert Einstein College of Medicine
Ketogenic Diet in Advanced Cancer	NCT01716468	Cancer	Ketogenic Diet	18 Years -	VA Pittsburgh Healthcare System
Ketogenic Diet in Advanced Cancer	NCT01716468	Cancer	Ketogenic Diet	18 Years -	VA Pittsburgh Healthcare System
Comparison of Healthy Diets on Breast Cancer Markers	NCT02744079	Breast Neoplasm...	Low carbohydrat... Low fat diet	21 Years -	Albert Einstein College of Medicine
Ketogenic Diet in Advanced Cancer	NCT01716468	Cancer	Ketogenic Diet	18 Years -	VA Pittsburgh Healthcare System

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