Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00828984
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date October 2009
Completion date October 2014

See also
  Status Clinical Trial Phase
Completed NCT04444232 - Cancer Communication Within Hispanic Social Networks N/A
Recruiting NCT06233253 - Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy N/A
Recruiting NCT05799820 - QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC Phase 2
Recruiting NCT04666727 - Role of Diet on the Microbiome of the Digestive System
Recruiting NCT04767984 - Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis Phase 2
Recruiting NCT02376452 - Phase II Study of 2-weekly RAILIRI Versus FOLFIRI as Second-line Treatment in Advanced Colorectal Cancer Patients Phase 2
Completed NCT02254486 - Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus Trisulfate Solution Using 2-Day Split-Dosing Regimen in Adults Phase 3
Completed NCT01486251 - Assessment of Tumor Vascular Effects of Axitinib With Dynamic Ultrasonography in Patients With Metastatic Colorectal Cancer N/A
Terminated NCT01233544 - Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases Phase 3
Recruiting NCT02073500 - Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies
Completed NCT00704600 - Nelfinavir, a Phase I/Phase II Rectal Cancer Study Phase 1/Phase 2
Completed NCT00485316 - Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma Phase 3
Recruiting NCT04430738 - Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers Phase 1/Phase 2
Terminated NCT02669914 - MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors Phase 2
Completed NCT05022511 - Three Birds With One Stone N/A
Not yet recruiting NCT03969784 - Microparticles in Peritoneal Carcinomatosis of Colorectal Origin N/A
Completed NCT04607291 - Health Service Intervention for the Improvement of Access and Adherence to Colorectal Cancer Screening Phase 1
Not yet recruiting NCT05630794 - Testing ONC201 to Prevent Colorectal Cancer Phase 1
Terminated NCT05291988 - A Multilevel Approach for Improvement in Screening of Colorectal Cancer in Rural Communities, The Screen to Save Trial N/A
Suspended NCT04108481 - Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer Phase 1/Phase 2