Stage IV Breast Cancer AJCC v6 and v7
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTDietary Intervention
Undergo ketogenic diet
OTHERLaboratory Biomarker Analysis
Correlative studies
DRUGPaclitaxel
Given standard of care therapy with paclitaxel
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence and compliance to the ketogenic diet | 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. |
| Changes in psychosocial measures | 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. |
| Changes in physiologic outcomes | 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. |
Countries
United States
Outcome results
None listed