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

Last updated: June 5, 2025
Sponsor: Ohio State University Comprehensive Cancer Center
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

Questionnaire Administration

Paclitaxel

Quality-of-Life Assessment

Clinical Study ID

NCT03535701
OSU-16289
NCI-2017-01168
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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=participanthas either normal activity, 1= participant has some symptoms but is nearly fullambulatory)

  • Life expectancy > 6 months

  • Able and willing to follow prescribed diet intervention

Exclusion

Exclusion Criteria:

  • Prior chemotherapy for metastatic breast cancer (MBC) (prior adjuvant chemotherapypermitted 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 ofketoacidosis

  • 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 studyrequirements

Study Design

Total Participants: 20
Treatment Group(s): 5
Primary Treatment: Questionnaire Administration
Phase: 1
Study Start date:
October 20, 2017
Estimated Completion Date:
May 01, 2020

Study 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.

Connect with a study center

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210
    United States

    Site Not Available

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