Stage IV Breast Cancer AJCC v6 and v7Phase 1KETO-CARENCT03535701
Ketogenic Diet and Chemotherapy in Affecting Recurrence in Patients With Stage IV Breast Cancer
A Phase 1 study testing Dietary Intervention, Laboratory Biomarker Analysis and Paclitaxel in people with Stage IV Breast Cancer AJCC v6 and v7, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Breast Cancer AJCC v6 and v7
- What is being tested?
- Dietary Intervention, Laboratory Biomarker Analysis and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2017to 1 May 2020
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Stage IV Breast Cancer AJCC v6 and v7
- Being tested
- Dietary Intervention, Laboratory Biomarker Analysis, Paclitaxel, Quality-of-Life Assessment, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionDietary supplement
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Undergo ketogenic diet
Laboratory Biomarker AnalysisOther
Correlative studies
PaclitaxelDrug
Also called Anzatax, Asotax, Bristaxol, Praxel
Given standard of care therapy with paclitaxel
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (standard of care) | Active comparator | Patients receive standard of care therapy with paclitaxel. Receives: Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (standard of care, ketogenic diet) | Experimental | 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. Receives: Dietary Supplement: Dietary Intervention; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 26 weeks
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.
Measured: Baseline up to 26 weeks
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.
Measured: Baseline up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start20 Oct 2017
- Primary completion1 Mar 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage IV Breast Cancer AJCC v6 and v7Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff Volek, Ohio State University Comprehensive Cancer Center
- Investigators
- Jeff Volek, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535701
- Sponsor's protocol ID
- OSU-16289
- Other IDs
- NCI-2017-01168
- Acronym
- KETO-CARE
- Status last verified
- Jun 2025
- First submitted
- 9 May 2018
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buga A, Harper DG, Sapper TN, Hyde PN, Fell B, Dickerson R, Stoner JT, Kackley ML, Crabtree CD, Decker DD, Robinson BT, Krystal G, Binzel K, Lustberg MB, Volek JS. Feasibility and metabolic outcomes of a well-formulated ketogenic diet as an adjuvant therapeutic intervention for women with stage IV metastatic breast cancer: The Keto-CARE trial. PLoS One. 2024 Jan 2;19(1):e0296523. doi: 10.1371/journal.pone.0296523. eCollection 2024.
PubMed 38166036