Ketogenic Diet and Chemotherapy in Affecting Recurrence in Patients With Stage IV Breast Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/26/2018 |
| Start Date: | October 20, 2017 |
| End Date: | August 1, 2019 |
| Contact: | The Ohio State University Comprehensive Cancer Center |
| Email: | OSUCCCClinicaltrials@osumc.edu |
| Phone: | 800-293-5066 |
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.
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.
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.
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
We found this trial at
1
site
Columbus, Ohio 43210
Principal Investigator: Jeff Volek
Phone: 614-688-1701
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