Ketogenic Diet and Chemotherapy in Affecting Recurrence in Patients With Stage IV Breast Cancer

• Status: Completed
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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