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Ketogenic Diet and Chemotherapy in Affecting Recurrence in Patients With Stage IV Breast Cancer (KETO-CARE)

Primary Purpose

Stage IV Breast Cancer AJCC v6 and v7

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention
Laboratory Biomarker Analysis
Paclitaxel
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stage IV Breast Cancer AJCC v6 and v7

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio State University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (standard of care)

Arm II (standard of care, ketogenic diet)

Arm Description

Patients receive standard of care therapy with paclitaxel.

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.

Outcomes

Primary Outcome Measures

Adherence and compliance to the ketogenic diet
Summaries from diet assessments and ketone logs will be plotted over time to assess adherence and compliance to the ketogenic diet.
Changes in psychosocial measures
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.
Changes in physiologic outcomes
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.

Secondary Outcome Measures

Full Information

First Posted
May 9, 2018
Last Updated
September 7, 2021
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03535701
Brief Title
Ketogenic Diet and Chemotherapy in Affecting Recurrence in Patients With Stage IV Breast Cancer
Acronym
KETO-CARE
Official Title
Ketogenic Diet and Chemotherapy to Affect Recurrence of Breast Cancer (The KETO-CARE Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 20, 2017 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Breast Cancer AJCC v6 and v7

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (standard of care)
Arm Type
Active Comparator
Arm Description
Patients receive standard of care therapy with paclitaxel.
Arm Title
Arm II (standard of care, ketogenic diet)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Intervention
Other Intervention Name(s)
Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Intervention Description
Undergo ketogenic diet
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Intervention Description
Given standard of care therapy with paclitaxel
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Adherence and compliance to the ketogenic diet
Description
Summaries from diet assessments and ketone logs will be plotted over time to assess adherence and compliance to the ketogenic diet.
Time Frame
Up to 26 weeks
Title
Changes in psychosocial measures
Description
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.
Time Frame
Baseline up to 26 weeks
Title
Changes in physiologic outcomes
Description
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.
Time Frame
Baseline up to 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Volek, PhD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

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

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