Ketogenic Diet and Chemotherapy in Affecting Recurrence in Patients With Stage IV Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-20

Study Completion Date

2020-05-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stage IV Breast Cancer AJCC v6 and v7

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (standard of care)

Patients receive standard of care therapy with paclitaxel.

Group Type ACTIVE_COMPARATOR

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Paclitaxel

Intervention Type DRUG

Given standard of care therapy with paclitaxel

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Dietary Intervention

Intervention Type DIETARY_SUPPLEMENT

Undergo ketogenic diet

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Paclitaxel

Intervention Type DRUG

Given standard of care therapy with paclitaxel

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Dietary Intervention

Undergo ketogenic diet

Intervention Type DIETARY_SUPPLEMENT

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Paclitaxel

Given standard of care therapy with paclitaxel

Intervention Type DRUG

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Dietary Modification intervention, dietary Nutrition Intervention Nutrition Interventions Nutritional Interventions Anzatax Asotax Bristaxol Praxel Taxol Taxol Konzentrat Quality of Life Assessment

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No