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Dietary Changes + Canagliflozin for Metastatic Breast Cancer
Study Summary
This trial will study whether a low-carb or ketogenic diet, or the drug canagliflozin, can help prevent high blood sugar and improve the effectiveness of cancer therapy in people with metastatic PIK3CA-mutant breast cancer who are receiving standard treatment with alpelisib and fulvestrant.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have an allergy or intolerance to eggs, gluten, nuts, or milk that would make it hard for you to follow the diet.My diabetes is not under control (A1c is 8.0 or higher).My cancer has a PIK3CA mutation.I am unable to make decisions for myself.My breast cancer is HR-positive and HER2-negative.I am 18 years old or older.You weigh less than what is considered healthy for your height.My cancer can be measured by scans or I have at least one bone lesion.I am not allergic to alpelisib, fulvestrant, canagliflozin, or their ingredients.My cancer came back or got worse after hormone therapy.I have or had skin cancer or cervical cancer but it was treated with the goal of curing it.I have had only one chemotherapy treatment for my cancer that has spread.I am currently in a weight loss program or on a ketogenic diet.I have Type 1 diabetes.I am fully active or restricted in physically strenuous activity but can do light work.You only eat vegetarian or vegan food.You are expected to live for at least 6 more months.My fasting blood sugar is under 140 mg/dL, my HbA1c is below 8%, and I only take metformin for it.My blood tests for organ function and blood cell counts are within normal ranges.I can take pills by mouth.I am postmenopausal.I have type 2 diabetes and am treated with specific diabetes medications or insulin.My cancer has enough tissue or blood samples for PIK3CA mutation testing.
- Group 1: Ketogenic Diet
- Group 2: Low Carbohydrate Diet
- Group 3: SGLT2i Therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the Ketogenic Diet a popular research topic?
"The ketogenic diet was first put under scientific scrutiny in 2004 at Lowell General Hospital. As of right now, there have been a total of 226 completed clinical trials. Out of these, 167 are actively recruiting participants. Many of these trials are being conducted in Basking Ridge, New jersey."
What are some of the benefits that patients see from following a Ketogenic Diet?
"The ketogenic diet is most popularly known for its role in breast cancer treatment, but it has also been linked with improvements in cardiovascular disease, disease progression, and exercise performance."
Has the Ketogenic Diet been federally recognized?
"Given that this is a Phase 2 trial, meaning that there is only preliminary data supporting safety, our team at Power has given Ketogenic Diet a 2."
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