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Completed

NCT Number: NCT03535701

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

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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Key information

Conditions

Stage IV Breast Cancer AJCC v6 and v7

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dietary intervention

Dietary Supplement

Undergo ketogenic diet

Other names: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

laboratory biomarker analysis

Other

Correlative studies

paclitaxel

Drug

Given standard of care therapy with paclitaxel

Other names: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Ketogenic Diet and Chemotherapy to Affect Recurrence of Breast Cancer (The KETO-CARE Study)

Acronym: KETO-CARE

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 24, 2018
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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