A randomized controlled trial of metformin in women with components of metabolic syndrome: Intervention feasibility and effects on adiposity and breast density

Autor: Edgar Tapia, Diana Evelyn Villa-Guillen, Maria I. Altbach, Jessica A. Martinez, Liane Pinto, Amit M. Algotar, Sara M. Centuori, Cynthia A. Thomson, Jesse Trujillo, Jose M. Guillen-Rodriguez, Jean-Phillippe Galons, H-H. Sherry Chow, Denise J. Roe, Pavani Chalasani, Chuan Huang
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Breast Cancer Res Treat
Popis: PURPOSE: Obesity is a known risk factor for post-menopausal breast cancer and may increase risk for triple negative breast cancer in premenopausal women. Intervention strategies are clearly needed to reduce obesity-associated breast cancer risk. METHODS: We conducted a Phase II double-blind, randomized, placebo-controlled trial of metformin in overweight/obese premenopausal women with components of metabolic syndrome to assess the potential of metformin for primary breast cancer prevention. Eligible participants were randomized to receive metformin (850 mg BID, n = 76) or placebo (n = 75) for 12 months. Outcomes included breast density, assessed by fat/water MRI with change in percent breast density as the primary endpoint, anthropometric measures, and intervention feasibility. RESULTS: Seventy-six percent in the metformin arm and 83% in the placebo arm (p = 0.182) completed the 12-month intervention. Adherence to study agent was high with more than 80% of participants taking ≥80% assigned pills. The most common adverse events reported in the metformin arm were gastrointestinal in nature and subsided over time. Compared to placebo, metformin intervention led to a significant reduction in waist circumference (p
Databáze: OpenAIRE