NCT03535701

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Stage IV Breast Cancer AJCC v6 and v7

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dietary Intervention	Undergo ketogenic diet
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Paclitaxel	Given standard of care therapy with paclitaxel
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2017-10-20
• Primary completion: 2020-03-01
• Completion: 2020-05-01
• First posted: 2018-05-24
• Last updated: 2025-06-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study