Colorectal Neoplasms Clinical Trial
Official title:
Pilot Study: Effect of Metformin on Biomarkers of Colorectal Tumor Cell Growth
The purpose of this study is to investigate the effects of short term oral Metformin therapy
on biomarkers for tumor growth in subjects with newly diagnosed colon or rectal
adenocarcinoma.
It is hypothesized that there are independent actions of Metformin on the outcome of
subjects with colorectal cancer (CRC). Also hypothesized is that metformin effects on CRC
cell growth will correlate with this drug's effects on markers mentioned above, because the
markers are closely related to tumor growth and metastases.
This is a randomized, double-blinded placebo controlled clinical investigation of the
effects of short term oral Metformin therapy on biomarkers for tumor growth in subjects with
newly diagnosed colon or rectal adenocarcinoma. Metformin is a well-tolerated drug widely
prescribed for treatment of Type 2 diabetes mellitus. Preliminary studies have generated the
hypothesis that metformin may have positive effects on both prevention and survival of colon
cancer subjects. Clinical trials are ongoing to explore this possibility in breast cancer
(NCT01101438). This investigation is the first study of Metformin in colorectal cancer (CRC)
patients, and is designed to understand the mechanism of its anti-cancer actions, if any,
and its interactions with biomarkers in colorectal cancer patients.
Based upon epidemiological studies, it is hypothesized that there are independent actions of
Metformin on the outcome of subjects with CRC. Also hypothesized is that metformin effects
on CRC cell growth will correlate with this drug's effects on markers mentioned above,
because the markers are closely related to tumor growth and metastases.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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