NCT02278965

Metformin and Omega-3 Fatty Acids in Woman With a History of Early Stage Breast Cancer

Pilot Biomarker Modulation Study of Metformin and Omega-3 Fatty Acids in Woman With a History of Early Stage Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Katherine D. Crew · Academic / Other
• Sex: Female
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether it is feasible to give a combination of Metformin and omega-3 fatty acids for one year to women with a history of early stage breast cancer. We will also evaluate whether the metformin and omega-3 fatty acids combination causes changes in breast tissue, blood, and mammograms.

Detailed description

Metformin is a medication used to treat and prevent diabetes and omega-3 fatty acids has been shown to lower cholesterol and improve cardiovascular health. Research has shown that Metformin and omega-3 fatty acids may also be effective in preventing cancer. In this study, we want to find out what effects, good and/or bad, the Metformin and omega-3 fatty acids combination has on you and your risk of developing a new breast cancer.

Conditions

• Stage 0 Breast Carcinoma
• Breast Neoplasms
• Stage I Breast Carcinoma
• Stage II Breast Carcinoma
• Stage III Breast Carcinoma

Interventions

Type	Name	Description
DRUG	Metformin	Metformin 850mg, oral, twice a day for 12 months
DRUG	Omega-3 fatty acids	Omega-3 fatty acids 2 capsules (560 mg each) oral, twice a day for 12 months

Timeline

• Start date: 2015-01-22
• Primary completion: 2017-04-19
• Completion: 2017-04-19
• First posted: 2014-10-30
• Last updated: 2022-08-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study