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Metformin + Fasting for Breast Cancer
Study Summary
This trial is studying the effect of fasting and metformin on breast cancer growth. Metformin is a diabetes drug that is associated with a decreased risk of cancer. Intermittent fasting may protect cancer patients from the toxic effects of chemotherapy.
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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Who is running the clinical trial?
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- Pregnant women should not go without eating for a long time.I am 18 years old or older.Your creatinine levels are within the normal range for the hospital or clinic where you are being treated.My kidneys are functioning well enough to clear waste.I do not have someone to help me if needed.My breast cancer is early stage, HER2 positive, and hasn't spread to lymph nodes.My BMI is under 18.5.I am a woman under 50 with a specific type of breast cancer and planned for initial treatment.You are allergic or intolerant to metformin hydrochloride extended release.I am not breastfeeding if I start treatment with metformin hydrochloride extended release.Women who follow any type of intermittent fasting program.I have not used oral hormonal contraceptives or hormones in the last four weeks, except for vaginal creams and IUDs.I am a woman with a certain type of breast cancer (ER+ or PgR+) that is still operable.My breast cancer is triple negative.I have had chemotherapy and hormone therapy for breast cancer.I am not pregnant.I have a large tumor and chose not to have chemotherapy before surgery.I am mostly active and can care for myself.I agree to use birth control or abstain from sex during the study.I am diabetic or my fasting blood sugar is 126 mg/dL or higher.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.You must have at least 3,000 white blood cells per microliter of blood.You need to have enough infection-fighting white blood cells in your body.My liver is not working well due to chronic conditions.I have a history of experiencing symptoms due to low blood sugar.You have a platelet count of at least 100,000 per microliter of blood.I have had lactic acidosis in the past.I have had vitamin B12 deficiency or megaloblastic anemia.I am not taking topiramate or similar medications.Your AST and ALT levels in the blood are not more than 1.5 times the normal limit.I regularly take more than 80 mg of water pills.
- Group 1: Arm I (fasting, glucose monitoring, counseling, metformin)
- Group 2: Arm II (glucose monitoring)
- 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
To what extent is participation allowed in this clinical experiment?
"Unfortunately, this trial is no longer enrolling patients. Initial posting was on January 30th 2023 and the last update was recorded August 17th 2022. For those still looking to participate in a clinical study, there are currently 4610 trials recruiting for breast-related topics and 170 studies related to Nutritional Assessment with open enrollment slots."
How has Nutritional Assessment been traditionally employed for clinical purposes?
"Nutritional Assessment can be an effective modality for managing exercise-related issues, type 1 diabetes mellitus, and diabetic ketoacidosis."
Is the procedure of Nutritional Assessment considered a safe practice for patients?
"Although there is no data regarding the efficacy of Nutritional Assessment, existing safety studies have enabled us to assign it a score of 2."
What is the principal aim of this research project?
"The main endpoint of this experiment, to be measured within a span of 4-6 weeks from the Baseline, is to ascertain any Differences in adjacent DCIS (in presence of IBC) or intraepithelial neoplasia Ki67. Additionally, Alcohol consumption will be correlated with response biomarkers; Difference of M30 and Change in circulating biomarkers such as Homeostatic model assessment index, highly sensitive C-reactive protein, C-peptide etc., shall also be evaluated between arms. ANCOVA models will analyse associations among post values (after treatment), changes from baseline by study arms adjusting for baseline values"
Have any prior experiments sought to evaluate the impact of nutrition on health?
"Presently, 170 different research studies are active in the field of Nutritional Assessment. Of these ongoing trials, 43 are at Phase 3 status. Although a majority of those experiments taking place in Pittsburgh, Pennsylvania, 1903 medical sites across the world have trialled this therapy."
Are individuals currently able to join this trial?
"Unfortunately, this trial is no longer enrolled in the recruitment phase. It was initially advertised on January 30th 2023 and last updated August 17th 2022. There are presently 4610 studies looking for participants with breast-related conditions and 170 clinical trials relating to Nutritional Assessment that you could consider instead."
Who else is applying?
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