Ketogenic Diet for Breast Cancer

Overseen By Kayla Chamberlin, RN, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Must not be taking: Insulin, Oral hypoglycemics

Disqualifiers: Type I diabetes, Uncontrolled hypertension, End-stage organ disease, Genetic lipid disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is testing the effects of a ketogenic diet on patients with early stage breast cancer. Participants will keep to a ketogenic diet for 3 weeks prior to surgery.

Who Is on the Research Team?

Saba Shaikh, MD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

Inclusion Criteria

Have the ability in the opinion of the investigator to adhere to a ketogenic diet and comply with study requirements such as ability to participate in telemedicine, utilize apps on a smart device, measure glucose/ketones at home, accurately log food intake and exercise, prepare food that is in line with ketogenic diet

I am 18 years old or older.

Be willing and able to provide consent for the study

Exclusion Criteria

Known psychiatric or substance use disorders that would interfere with participation in the study

My high blood pressure is not controlled with medication.

My doctor recommends treatment before surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Dietary Education

Participants meet with a dietitian for education on a ketogenic diet and receive additional educational materials

1 week

Treatment

Participants adhere to a ketogenic diet for 3 weeks prior to surgery, with daily monitoring of serum glucose and ketones

3 weeks

Follow-up

Participants are monitored for changes in tumor immune microenvironment and quality of life assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ketogenic Diet

How Is the Trial Designed?

Group I: Ketogenic Diet Treatment arm Experimental Treatment 1 Intervention

Patients with early-stage breast cancer will adhere to a ketogenic diet for 3 weeks prior to surgery.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+