Breast Cancer Clinical Trial
Ketogenic Diet and Chemotherapy in Affecting Recurrence in Patients With Stage IV Breast Cancer
Summary
This pilot clinical trial studies how well a ketogenic diet and chemotherapy work in affecting the return of cancer in patients with stage IV breast cancer. Ketogenic diet may be more effective than standard nutrition and may affect quality of life, inflammation, and tumor-related changes. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ketogenic diet and chemotherapy may be better in patients with breast cancer.
Full Description
PRIMARY OBJECTIVES:
I. To evaluate the feasibility of implementing a diet that induces nutritional ketosis in women who are initiating palliative chemotherapy to treat advanced stage breast cancer (BC).
II. To determine the effects of a ketogenic diet on tumor progression. III. To determine the effects of nutritional ketosis on biologic and behavioral health markers.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I: Patients receive standard of care therapy with paclitaxel.
ARM II: Patients receive standard of care with paclitaxel. Patients undergo a controlled feeding period ketogenic diet comprising of meals prepared in the research kitchen for 3 months. Beginning 2 weeks prior to completion of the controlled feeding period, patients also undergo free living ketogenic diet program for 3 months comprising of group format, individual sessions, and online digital content to educate patients to implement a ketogenic eating pattern into their lifestyle.
Eligibility Criteria
Inclusion Criteria:
Body mass index (BMI) >= 22 kg/m^2
Confirmed diagnosis of metastatic or stage IV BC
Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET) avid tumors
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (0=participant has either normal activity, 1= participant has some symptoms but is nearly full ambulatory)
Life expectancy > 6 months
Able and willing to follow prescribed diet intervention
Exclusion Criteria:
Prior chemotherapy for metastatic breast cancer (MBC) (prior adjuvant chemotherapy permitted as long as > 12 months [mo])
BMI < 25 kg/m^2
Weight change > 5% within 3 months of enrollment
Type 1 diabetes
History of diabetes with retinopathy requiring treatment
Current use of insulin or sulfonylureads for glycemic control, or history of ketoacidosis
Intestinal obstruction
Bilirubin > 2
Albumin < 3.5
Glomerular filtration rate (GFR) < 55 mL/min
Creatinine > 2.0
Urinary albumin > 1 g/day
Congestive heart failure
Pregnant or nursing women
Unable to provide informed consent
Uncontrolled concurrent medical conditions that would limit compliance with study requirements
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There is 1 Location for this study
Columbus Ohio, 43210, United States
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