Ketogenic Diet and Chemotherapy in Affecting Recurrence in Patients With Stage IV Breast Cancer (KETO-CARE)

The Ohio State University

Status and phase: Completed; Phase 1

Conditions: Stage IV Breast Cancer AJCC v6 and v7

Treatments: Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Dietary Supplement: Dietary Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT03535701

NCI-2017-01168 (Registry Identifier)

OSU-16289

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Arm I (standard of care)

Active Comparator group

Description:

Patients receive standard of care therapy with paclitaxel.

Treatment:

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Drug: Paclitaxel

Other: Laboratory Biomarker Analysis

Arm II (standard of care, ketogenic diet)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Dietary Supplement: Dietary Intervention

Drug: Paclitaxel

Other: Laboratory Biomarker Analysis