This randomized phase II trial studies how well macrogol 3350-based oral osmotic laxative (polyethylene glycol 3350) works in preventing cancer in patients at risk of colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of macrogol 3350-based oral osmotic laxative may stop cancer from growing in patients who are at risk of colorectal cancer.
PRIMARY OBJECTIVES: I. To evaluate the effect of polyethylene glycol (PEG) 3350 (administered at 8 g or 17 g/day for six months) versus placebo on epidermal growth factor receptor (EGFR) expression. SECONDARY OBJECTIVES: I. To determine the effect of PEG 3350 on aberrant crypt foci (ACF) number and to compare the reduction in ACF number between the low dose (8 g PEG 3350/day) and higher dose (17 g PEG 3350/day) groups. II. To determine the effect of PEG 3350 on mucosal epithelial proliferation (marker of proliferation Ki-67 \[Ki-67\]). III. To determine the effect of PEG 3350 on mucosal apoptosis (cleaved caspase-3). IV. To determine the effect of PEG 3350 on snail family zinc finger 1 (SNAIL) protein expression. V. To determine the effect of PEG 3350 on messenger ribonucleic acid (mRNA) expression of SNAIL and EGFR. OUTLINE: Patients are randomized to 1 of 3 treatment arms. ARM A: Patients receive high-dose macrogol 3350-based oral osmotic laxative orally (PO) once daily (QD). ARM B: Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. ARM C: Patients receive placebo (i.e., maltodextrose powder) PO QD. In all arms, treatment begins within 6-10 days after colonoscopy and continues for up to 6 months in the absence of unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
87
University of Chicago
Chicago, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
Boston Medical Center
Boston, Massachusetts, United States
Difference (After Treatment Minus Before Treatment) of EGFR Expression
Evaluate the effect of polyethylene glycol (PEG) 3350 (administered at 8g or 17g/day for six months) versus placebo on EGFR expression.
Time frame: 6 months - baseline
Change in ACF Count as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies
To determine the effect of PEG 3350 on aberrant crypt foci (ACF) number and to compare the reduction in ACF number between the low dose (8g PEG 3350 / day) and higher dose (17g PEG 3350 / day) groups
Time frame: 6 months - baseline
Change in Ki-67 (Proliferation) Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies
To determine the effect of PEG 3350 on mucosal epithelial proliferation (Ki-67)
Time frame: 6 months - baseline
Change in Mucosal Apoptosis (Cleaved Caspase-3) as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies
Change in activated caspase-3 (apoptosis) expression as measured in endoscopically normal (non-ACF) mucosal biopsies
Time frame: 6 months - baseline
Change in SNAIL Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies
Time frame: 6 months - baseline
Change in E-cadherin Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies
Time frame: 6 months - baseline
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