- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03535701
Ketogenic Diet and Chemotherapy in Affecting Recurrence in Patients With Stage IV Breast Cancer (KETO-CARE)
Ketogenic Diet and Chemotherapy to Affect Recurrence of Breast Cancer (The KETO-CARE Study)
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
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
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Disease Attributes
- Breast Diseases
- Breast Neoplasms
- Recurrence
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- OSU-16289
- NCI-2017-01168 (REGISTRY: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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