Ketogenic Diet and Chemotherapy in Affecting Recurrence in Patients With Stage IV Breast Cancer (KETO-CARE)
June 5, 2025 updated by: Jeff Volek, Ohio State University Comprehensive Cancer Center
Ketogenic Diet and Chemotherapy to Affect Recurrence of Breast Cancer (The KETO-CARE Study)
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Arm I (standard of care)
Patients receive standard of care therapy with paclitaxel.
|
Correlative studies
Ancillary studies
Other Names:
Ancillary studies
Given standard of care therapy with paclitaxel
Other Names:
|
|
Experimental: Arm II (standard of care, ketogenic diet)
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.
|
Correlative studies
Ancillary studies
Other Names:
Ancillary studies
Undergo ketogenic diet
Other Names:
Given standard of care therapy with paclitaxel
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence and compliance to the ketogenic diet
Time Frame: Up to 26 weeks
|
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
|
|
Changes in psychosocial measures
Time Frame: Baseline up to 26 weeks
|
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
|
|
Changes in physiologic outcomes
Time Frame: Baseline up to 26 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jeff Volek, PhD, Ohio State University Comprehensive Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2017
Primary Completion (Actual)
March 1, 2020
Study Completion (Actual)
May 1, 2020
Study Registration Dates
First Submitted
May 9, 2018
First Submitted That Met QC Criteria
May 22, 2018
First Posted (Actual)
May 24, 2018
Study Record Updates
Last Update Posted (Actual)
June 8, 2025
Last Update Submitted That Met QC Criteria
June 5, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Disease Attributes
- Skin Diseases
- Breast Diseases
- Recurrence
- Breast Neoplasms
- Antineoplastic Agents
- Molecular Mechanisms of Pharmacological Action
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Albumin-Bound Paclitaxel
- Paclitaxel
Other Study ID Numbers
- OSU-16289
- NCI-2017-01168 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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