Impact of Pretreatment With Metformin on Colorectal Cancer Stem Cells (CCSC) and Related Pharmacodynamic Markers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01440127|
Recruitment Status : Terminated (Unable to accrue all planned subjects in a timely fashion, but data collected will still be analyzed.)
First Posted : September 26, 2011
Last Update Posted : March 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Drug: Metformin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Clinical Trial Evaluating the Impact of Pretreatment With Metformin on Colorectal Cancer Stem Cells (CCSC) and Related Pharmacodynamic Markers|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
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.
- Expression of CD133 in tumors from patients treated or not treated with metformin [ Time Frame: 2-weeks of metformin treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440127
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Wasif Saif, MD||Tufts Medical Center|