NCT00828984

Macrogol 3350-based Oral Osmotic Laxative in Preventing Cancer in Patients at Risk of Colorectal Cancer

Polyethylene Glycol for ACF Reduction and Biomarker Modulation in Individuals With CRC Risk

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Adenomatous Polyp
• Colorectal Carcinoma

Interventions

Type	Name	Description
DRUG	macrogol 3350-based oral osmotic laxative	Given PO
OTHER	Placebo	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2009-10-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2009-01-26
• Last updated: 2017-04-18
• Results posted: 2017-01-19

Locations

3 sites across 1 country: United States