12 Participants NeededMy employer runs this trial

Ketogenic Diet for Breast Cancer

JT
KC
Overseen ByKayla Chamberlin, RN, BSN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of a ketogenic diet on patients with early-stage breast cancer who are preparing for surgery. Participants will follow a ketogenic diet for three weeks before surgery to assess its impact on their cancer. Those diagnosed with Stage I or II breast cancer and planning for surgery without pre-operative treatments may find this study suitable. Participants must adhere to the diet and use apps to track meals and exercise. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on dietary impacts on cancer.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the ketogenic diet is safe for breast cancer patients?

Research has shown that the ketogenic diet, low in carbs and high in fat, yields mixed results for cancer patients. Some studies suggest it can help by reducing body fat, insulin, and blood sugar levels, and by decreasing tiredness and sleep problems. However, concerns exist about its safety, particularly the long-term effects of ketosis, where the body uses fat for energy instead of carbs.

One study found that a ketogenic diet might increase the risk of cancer spreading. Another study suggested that high-fat diets could promote tumor growth. On the positive side, some patients have safely maintained ketosis and improved their body condition during chemotherapy. Overall, while the ketogenic diet may offer benefits, it also presents risks that require careful consideration.12345

Why are researchers excited about this trial?

Unlike the standard treatments for breast cancer, which typically include surgery, chemotherapy, radiation, and hormone therapy, the ketogenic diet offers a unique, non-invasive approach. Researchers are excited about this treatment because it focuses on altering the body's metabolism by reducing carbohydrate intake, which may slow cancer cell growth by depriving them of glucose. This dietary approach is particularly intriguing as it could complement existing therapies by potentially improving their effectiveness or reducing side effects. Plus, it provides an option that might empower patients to take an active role in their treatment through dietary changes.

What evidence suggests that a ketogenic diet might be an effective treatment for breast cancer?

Research suggests that a ketogenic diet might help breast cancer patients. This trial will evaluate the effects of a ketogenic diet on patients with early-stage breast cancer, who will follow the diet for 3 weeks before surgery. The ketogenic diet can lower blood sugar and insulin levels, which are important for tumor growth. Some studies have shown that the ketogenic diet may benefit cancer patients by reducing inflammation, lowering insulin levels, and improving overall health. However, other studies have indicated that a high-fat diet like keto could increase the risk of cancer spreading. While there are promising signs, the evidence remains mixed, and more research is needed to fully understand its effects on breast cancer.12345

Who Is on the Research Team?

SS

Saba Shaikh, MD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for postmenopausal women aged 18 or older with early stage (I or II) breast cancer who are scheduled for surgery in at least 3 weeks, can follow a ketogenic diet, use smart devices to track health data, and have no major health issues that would make participation unsafe.

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
See 5 more

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.
See 16 more

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

Trial Overview

The study tests whether following a strict ketogenic diet for 3 weeks before breast cancer surgery affects the tumor environment. Participants will be closely monitored while on this special low-carb, high-fat diet.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Ketogenic Diet Treatment armExperimental Treatment1 Intervention

Find a Clinic Near You

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+

Citations

Ketogenic Diet and Breast Cancer: Recent Findings ... - PMC

Emerging evidence suggests that a KD possesses potential anticancer properties, such as inhibiting tumor growth, shielding normal cells from chemotherapy or ...

Ketogenic diets: Dietary therapeutic potential on breast ...

Emerging evidence shows that KD, whether used alone or in combination with standard care, can directly influence tumor cell metabolism and reduces the risk of ...

Impact of ketogenic diets on cancer patient outcomes - PMC

The ketogenic diet was found to improve cancer patients' outcomes more effectively than non-ketogenic diets. Notably, C-reactive protein levels ...

Ketogenetic Diet Combined with Metastatic Tumor Therapies ...

Combining ketogenic diets with existing cancer therapies, specifically Fulvestrant, can improve therapeutic outcomes.

Impact of ketogenic diets on cancer patient outcomes

This meta-analysis revealed that the ketogenic diet significantly reduced fat mass, visceral fat, insulin levels, blood glucose, fatigue, and insomnia