Metformin + Fasting for Breast Cancer
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot participate if you are using oral hormonal contraceptives, female hormones, topiramate, or other carbonic anhydrase inhibitors. It's best to discuss your current medications with the study team.
What data supports the idea that Metformin + Fasting for Breast Cancer is an effective treatment?
The available research shows that combining fasting with treatments for hormone-receptor-positive breast cancer can enhance their effectiveness. For example, fasting increases the activity of drugs like tamoxifen and fulvestrant, which are used to treat this type of breast cancer. It does this by lowering certain hormones and proteins in the blood, like insulin and IGF1, which are linked to cancer growth. Additionally, fasting helps prevent some side effects of these treatments. Another study found that intermittent fasting can make tumors more sensitive to metformin, a drug that reduces tumor growth. These findings suggest that fasting, when combined with certain breast cancer treatments, can improve their effectiveness and reduce side effects.12345
What safety data exists for Metformin and fasting in breast cancer treatment?
The research provided does not directly address the safety of Metformin combined with fasting for breast cancer treatment. However, it includes studies on time-restricted eating (TRE) and Metformin in the context of type 2 diabetes. These studies suggest that TRE is generally safe for people with type 2 diabetes when medication is monitored and adjusted. Metformin is commonly used in these contexts, indicating it is generally considered safe with fasting in diabetes management. More specific studies are needed to determine the safety of this combination for breast cancer treatment.678910
Is Metformin Hydrochloride Extended Release with Nightly Fasting a promising treatment for breast cancer?
What is the purpose of this trial?
This phase IIb trial studies the combined effect of prolonged nightly fasting and metformin hydrochloride extended release in decreasing breast tumor cell proliferation and other biomarkers of breast cancer. Preventing invasive breast cancer or DCIS. Metformin is widely used to treat type II diabetes and is associated with a decreased risk of cancer and death in diabetic individuals. Intermittent fasting may protect cancer patients from the toxic effects of chemotherapy agents without causing chronic weight loss. The combination of intermittent fasting and metformin may reduce breast cancer growth and may be used in women at risk for breast cancer or other cancers associated with being overweight.
Research Team
Parijatham Thomas, MD
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for women over 18 with early-stage breast cancer (ER+ve and/or PgR+ve) who are fit for surgery but not receiving neoadjuvant therapy. They must have normal organ function, no prior breast cancer treatment, and agree to use contraception. Excluded are those with serious illnesses, low BMI, diabetes or glucose intolerance, metformin allergies, current investigational drug use, recent hormone treatments excluding IUDs/vaginal creams, pregnant/breastfeeding women, intermittent fasters.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants fast for >= 16 hours every night and use the continuous glucose monitoring system for 4-6 weeks. They receive nutritional counseling and metformin hydrochloride extended release until the day of surgery.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including the collection of blood and tissue samples.
Treatment Details
Interventions
- Metformin Hydrochloride Extended Release
- Nightly Fasting
Metformin Hydrochloride Extended Release is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Type 2 diabetes mellitus
- Type 2 diabetes mellitus
- Type 2 diabetes mellitus
- Type 2 diabetes mellitus
- Type 2 diabetes mellitus
- Type 2 diabetes mellitus
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator