Impact of Pretreatment With Metformin on Colorectal Cancer Stem Cells (CCSC) and Related Pharmacodynamic Markers
Metformin is drug that is normally used to treat people with diabetes. New research has discovered that metformin may also kill cancer stem cells. These cancer stem cells make up only a small portion of a cancer, but may be responsible for resistance to chemotherapy or for causing recurrence of the cancer. The purpose of this study is to determine the effect of metformin on colorectal cancer tumors. The study is designed to develop the methods to test tumors for cancer stem cells and then to determine the difference between treating with metformin and not treating with metformin with regard to the cancer stem cells. This research is investigational because the effect of metformin on cancer stem cells is not known in humans. Also, in patients who are not diabetic, metformin would normally not be given prior to surgery.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Clinical Trial Evaluating the Impact of Pretreatment With Metformin on Colorectal Cancer Stem Cells (CCSC) and Related Pharmacodynamic Markers|
- Expression of CD133 in tumors from patients treated or not treated with metformin [ Time Frame: 2-weeks of metformin treatment ] [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Subjects in this arm are randomized to receive metformin during the period of time between planning the surgery or biopsy and the actual procedure. After approximately 1 week of taking metformin, we will re-check the blood glucose. We will draw blood for cancer stem cells (about 2 teaspoons) and ask about symptoms. Subjects will stop taking metformin 2 days before the procedure.
Pills will be taken for one week prior to the scheduled surgery or biopsy procedure.
No Intervention: Observation
No metformin will be given prior to the scheduled surgery or biopsy.
|Contact: Robin Millis, RN, BSNemail@example.com|
|Contact: Jodi Jensen, RN, BSNfirstname.lastname@example.org|
|United States, Massachusetts|
|Tufts Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02111|
|Contact: Robin Millis, RN, BSN 617-636-9161 email@example.com|
|Contact: Jodi Jensen, RN, BSN 617-636-5558 firstname.lastname@example.org|
|Sub-Investigator: Robert Martell, MD, PhD|
|Sub-Investigator: Furha Cossor, MD, MS|
|Sub-Investigator: Bruce Orkin, MD|
|Sub-Investigator: Martin Goodman, MD|
|Sub-Investigator: Daniel Popowich, MD|
|Principal Investigator: Wasif Saif, MD|
|Principal Investigator:||Wasif Saif, MD||Tufts Medical Center|