Ketogenic Diet and Chemotherapy in Affecting Recurrence in Patients With Stage IV Breast Cancer
KETO-CARE
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2017
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 20, 2017
CompletedFirst Submitted
Initial submission to the registry
May 9, 2018
CompletedFirst Posted
Study publicly available on registry
May 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedJune 8, 2025
June 1, 2025
2.4 years
May 9, 2018
June 5, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (2)
Arm I (standard of care)
ACTIVE COMPARATORPatients receive standard of care therapy with paclitaxel.
Arm II (standard of care, ketogenic diet)
EXPERIMENTALPatients 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.
Interventions
Undergo ketogenic diet
Correlative studies
Given standard of care therapy with paclitaxel
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeff Volek, PhD
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 9, 2018
First Posted
May 24, 2018
Study Start
October 20, 2017
Primary Completion
March 1, 2020
Study Completion
May 1, 2020
Last Updated
June 8, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share