Major Program
Cancer Prevention Clinical Trials Network
Research Group
Breast and Gynecologic Cancer
Sponsor
M.D. Anderson Cancer Center
Status
Recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT05023967
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.
Intervention
Biospecimen Collection, Extended Release Metformin Hydrochloride, Monitoring, Nutritional Assessment, Short-Term Fasting
Condition
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma
Investigators
Parijatham Thomas, MD, Bernardo Bonanni, MD, Andrea De Censi