Status:
WITHDRAWN
Metformin Use to Reduce Disparities in Newly Diagnosed Breast Cancer
Lead Sponsor:
Woman's
Collaborating Sponsors:
Our Lady of the Lake Hospital
American Cancer Society, Inc.
Conditions:
Breast Cancer Stage
Insulin Resistance
Eligibility:
FEMALE
18-80 years
Phase:
PHASE4
Brief Summary
Breast cancer is one of the most common malignancies in women globally, with \~1.4 million new cases diagnosed annually Breast cancer is one of the leading causes of cancer-related morbidity and morta...
Detailed Description
Even as cancer research has led to more advanced, targeted cancer treatments than ever before, not all patients are able to reap the benefits of these efforts, as demonstrated by their persistently wo...
Eligibility Criteria
Inclusion
- Non-Hispanic white or black females
- Age \> = 18 years
- English speaking
- Newly diagnosed breast cancer
- BMI \> = 25 (must be overweight)
- Insulin-resistant (as determined by 2 hour 75 gm oral glucose tolerance test (OGTT)). Concentrations and trajectories of insulin and glucose at 0, 30, 60, and 120 min during an oral glucose tolerance test will undergo mathematical modeling. The numbers for defining insulin resistance have been established in the Woman's Laboratory and are interpreted by the pathologists.
Exclusion
- Metastatic Disease
- Current diagnosis of Diabetes or diagnosed with diabetes (as determined by HbA1C\> 6.5)
- Having surgery prior to chemotherapy
- Medical conditions for which metformin is contraindicated (gastrointestinal and renal failure),
- Abnormal CBC (defined by a baseline platelet count of less than 130 and a baseline absolute neutrophil count of less than 1000). In addition, baseline hemoglobin of less than 10, if there is no evidence of a concurrent nutritional deficiency (like iron). \[Patients simply needing something like iron to correct the anemia will not be excluded\].
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04741204
Start Date
September 1 2022
End Date
September 1 2022
Last Update
July 6 2023
Active Locations (1)
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1
Woman's Hospital
Baton Rouge, Louisiana, United States, 70815