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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01168 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (standard of care) | Active Comparator | Patients receive standard of care therapy with paclitaxel. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Intervention | Dietary Supplement | Undergo ketogenic diet |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Volek, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Paclitaxel | Drug | Given standard of care therapy with paclitaxel |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D017239 | Paclitaxel |
| D013660 | Taxes |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
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