Clinical trial NCT03535701: Ketogenic Diet and Chemotherapy in Affecting Recurrence in Patients With Stage IV Breast Cancer
Official title: Ketogenic Diet and Chemotherapy to Affect Recurrence of Breast Cancer (The KETO-CARE Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stage IV Breast Cancer AJCC v6 and v7
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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

Primary outcomes:
measure: Adherence and compliance to the ketogenic diet
timeFrame: Up to 26 weeks
measure: Changes in psychosocial measures
timeFrame: Baseline up to 26 weeks
measure: Changes in physiologic outcomes
timeFrame: Baseline up to 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Jeff Volek, PhD
role: PRINCIPAL_INVESTIGATOR
References: