Metformin (Dimethylbiguanide) and Insulin Resistance in Women Completing Neoadjuvant and/or Adjuvant Cytotoxic Treatment of Stage I-III Breast Cancer
City of Hope Medical Center
Summary
This phase III trial evaluates how often women develop insulin resistance and type-2 diabetes and compares metformin with usual care to usual care alone in treating insulin resistance in women with stage I-III breast cancer after chemotherapy. Insulin resistance occurs when cells stop responding to insulin and is a risk factor for developing diabetes and heart disease. Higher levels of insulin have been shown to be associated with aggressive breast cancer. Metformin hydrochloride decreases the amount of glucose (a type of sugar) released into the bloodstream from the liver and increases the body's use of the glucose. Metformin as well as standard of care diet and exercise education is known to lower blood sugar. However, chemotherapy may accelerate metabolic disorders, such as high blood sugar, and the impact of metformin in these breast cancer survivors is not known. Giving metformin with usual care may be more effective than usual care alone in preventing or reversing insulin resistance in women with stage I-III breast cancer after chemotherapy.
Description
PRIMARY OBJECTIVE: I. To determine if extended release metformin hydrochloride (metformin) can normalize glycosylated hemoglobin (HgbA1c) (\< 5.7%) for women breast cancer survivors with HgbA1c between 5.7-6.4%. EXPLORATORY OBJECTIVES: I. To investigate whether metformin treatment of insulin resistance (versus standard of care alone) alters epigenetic changes (chromatin acetylation, chromatin opening, and methylation) and the level of inflammatory cytokines. (Pilot) II. To investigate whether normalization of HgbA1c alters epigenetic changes (chromatin acetylation, chromatin opening, and me…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Agreement to allow lab draw of approximately 26 mL of blood (less than 3 tablespoons) * To check blood counts, organ function and disease at baseline and 12 months * Clinical labs at baseline, 3 months, 6 months,12 months, and 24 months * Research labs at baseline, 6 months,12 months, and 24 months * Age: ≥ 18 years * Female sex assigned at birth * Ability to read and understand English or Spanish for questionnaires * Diagnosis of estrogen receptor (ER)-negative /HER2-wild ty…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- OtherEducational Intervention
Receive standard of care healthy diet and exercise handouts
- DrugExtended Release Metformin Hydrochloride
Given PO
- OtherQuestionnaire Administration
Ancillary studies
Locations (3)
- City of Hope Medical CenterDuarte, California
- UC San Diego Moores Cancer CenterLa Jolla, California
- University of California-RiversideRiverside, California