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

Stage IV Breast Cancer AJCC v6 and v7 Clinical Trial

— KETO-CARE  

Official title:

Ketogenic Diet and Chemotherapy to Affect Recurrence of Breast Cancer (The KETO-CARE Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03535701
• Other study ID #: OSU-16289
• Secondary ID: NCI-2017-01168
• Status: Completed
• Phase: N/A
• Start date: October 20, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: September 2021
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Recurrence
• Stage IV Breast Cancer AJCC v6 and v7

Intervention

Dietary Supplement:
• Dietary Intervention
Undergo ketogenic diet

Other:
• Laboratory Biomarker Analysis
Correlative studies

Drug:
• Paclitaxel
Given standard of care therapy with paclitaxel

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence and compliance to the ketogenic diet	Summaries from diet assessments and ketone logs will be plotted over time to assess adherence and compliance to the ketogenic diet.	Up to 26 weeks
Primary	Changes in psychosocial measures	Summary measures such as Cohens d will be used. Linear and nonlinear mixed models will be used as appropriate to model changes in tumor markers, comorbidity risk factors, and other measures over time, with emphasis will be on estimating effect sizes (such as slopes of change). Post hoc tests will be used to examine pairwise comparisons when significant main or interaction effects are observed. The alpha level for significance will be set at p =< 0.05.	Baseline up to 26 weeks
Primary	Changes in physiologic outcomes	Summary measures such as Cohens d will be used. Linear and nonlinear mixed models will be used as appropriate to model changes in tumor markers, comorbidity risk factors, and other measures over time, with emphasis will be on estimating effect sizes (such as slopes of change). Post hoc tests will be used to examine pairwise comparisons when significant main or interaction effects are observed. The alpha level for significance will be set at p =< 0.05.	Baseline up to 26 weeks

External Links

•   The Jamesline