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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low carbohydrate diet | Active Comparator | 45 subjects will receive a very low carbohydrate diet between a positive breast biopsy and surgical tumor removal |
|
| Low fat diet | Active Comparator | 20 subjects will receive a lo fat diet between a positive breast biopsy and surgical tumor removal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low carbohydrate diet | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| TUNEL comparison of each dietary intervention at surgical removal to measure change in apoptosis in tumor cells | 2 years | |
| Ki-67 comparison of each dietary intervention at surgical removal to measure change in proliferation of tumor cells | 2 years |
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Inclusion Criteria:
Women with biopsy proven breast cancer.
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Eugene J Fine, MD | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Albert Einstein College of Medicine of Yeshiva University | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22840388 | Background | Fine EJ, Segal-Isaacson CJ, Feinman RD, Herszkopf S, Romano MC, Tomuta N, Bontempo AF, Negassa A, Sparano JA. Targeting insulin inhibition as a metabolic therapy in advanced cancer: a pilot safety and feasibility dietary trial in 10 patients. Nutrition. 2012 Oct;28(10):1028-35. doi: 10.1016/j.nut.2012.05.001. Epub 2012 Jul 26. | |
| 24221746 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D018752 | Diet, Fat-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Low fat diet | Behavioral | 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. |
|
| Jain R, Strickler HD, Fine E, Sparano JA. Clinical studies examining the impact of obesity on breast cancer risk and prognosis. J Mammary Gland Biol Neoplasia. 2013 Dec;18(3-4):257-66. doi: 10.1007/s10911-013-9307-3. Epub 2013 Nov 13. |
| 19480693 | Background | Fine EJ, Miller A, Quadros EV, Sequeira JM, Feinman RD. Acetoacetate reduces growth and ATP concentration in cancer cell lines which over-express uncoupling protein 2. Cancer Cell Int. 2009 May 29;9:14. doi: 10.1186/1475-2867-9-14. |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |