Metformin Treatment to Improve Insulin Resistance in Women After Chemotherapy for Stage I-III Breast Cancer

What this Trial Is About

Researchers are studying how often women with stage I-III breast cancer develop insulin resistance and type-2 diabetes after chemotherapy. This phase III trial compares the use of extended release metformin combined with standard diet and exercise care to standard care alone in treating insulin resistance. Insulin resistance increases the risk of diabetes and heart disease, and higher insulin levels have been linked to more aggressive breast cancer. The study aims to determine if metformin can help normalize blood sugar levels in these breast cancer survivors. Participants are randomly assigned to one of two groups. One group receives standard diet and exercise education plus daily oral extended release metformin for 12 months, unless disease progression or unacceptable side effects occur. The other group receives only the standard diet and exercise education. Throughout the study, blood samples are collected to analyze biological changes. After completing the treatment period, participants have follow-up visits at 30 days and again at 12 months. During the study, women provide blood samples at multiple time points to assess blood sugar control and other markers related to inflammation and gene regulation. Questionnaires are also administered to support additional research. The main outcome measured is normalization of hemoglobin A1c, an indicator of blood sugar control, over 12 months. Secondary outcomes include monitoring this measure at 3, 6, 12, and 24 months. Safety and disease status are carefully tracked throughout the trial, which lasts up to two years from enrollment.

Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy