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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00828984
First Posted: January 26, 2009
Last Update Posted: April 18, 2017
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.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: November 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions: Adenomatous Polyp
Colorectal Carcinoma
Interventions: Drug: macrogol 3350-based oral osmotic laxative
Other: Placebo
Other: Laboratory Biomarker Analysis

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Age 18 and older; Recruitment sites: NorthShore University HealthSystem, University of Chicago, Boston University (no accrual occurred)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
History of any size adenoma or colon cancer within the last 6 years;

Reporting Groups
  Description
Arm A (High-dose PEG 3350)

Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.

17g day/macrogol 3350-based oral osmotic laxative: Given PO

Laboratory Biomarker Analysis: Correlative studies

Arm B (Low-dose Polyethylene Glycol)

Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.

8g day/macrogol 3350-based oral osmotic laxative: Given PO

Laboratory Biomarker Analysis: Correlative studies

Arm C (Placebo)

Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.

Placebo: Given PO

Laboratory Biomarker Analysis: Correlative studies


Participant Flow:   Overall Study
    Arm A (High-dose PEG 3350)   Arm B (Low-dose Polyethylene Glycol)   Arm C (Placebo)
STARTED   28   31   28 
Randomization   28   31   28 
Treatment   24   26   24 
Flexible Sigmoidoscopy   20   19   19 
Post Intervention Follow-Up   15   16   19 
COMPLETED   14   15   19 
NOT COMPLETED   14   16   9 
Adverse Event                2                3                0 
Lost to Follow-up                5                3                1 
Withdrawal by Subject                4                4                4 
Ineligable                1                2                0 
Medical Contraindication                0                1                0 
Noncompliant                1                2                3 
ConMed                1                1                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm A (High-dose PEG 3350)

Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.

macrogol 3350-based oral osmotic laxative: Given PO

Laboratory Biomarker Analysis: Correlative studies

Arm B (Low-dose Polyethylene Glycol)

Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.

macrogol 3350-based oral osmotic laxative: Given PO

Laboratory Biomarker Analysis: Correlative studies

Arm C (Placebo)

Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.

Placebo: Given PO

Laboratory Biomarker Analysis: Correlative studies

Total Total of all reporting groups

Baseline Measures
   Arm A (High-dose PEG 3350)   Arm B (Low-dose Polyethylene Glycol)   Arm C (Placebo)   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   31   28   87 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      19  67.9%      18  58.1%      18  64.3%      55  63.2% 
>=65 years      9  32.1%      13  41.9%      10  35.7%      32  36.8% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      14  50.0%      17  54.8%      12  42.9%      43  49.4% 
Male      14  50.0%      14  45.2%      16  57.1%      44  50.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      1   3.6%      2   6.5%      0   0.0%      3   3.4% 
Not Hispanic or Latino      27  96.4%      29  93.5%      28 100.0%      84  96.6% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      2   7.1%      2   2.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      4  14.3%      5  16.1%      0   0.0%      9  10.3% 
White      24  85.7%      26  83.9%      26  92.9%      76  87.4% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Difference (After Treatment Minus Before Treatment) of EGFR Expression   [ Time Frame: 6 months - baseline ]

2.  Secondary:   Change in ACF Count as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies   [ Time Frame: 6 months - baseline ]

3.  Secondary:   Change in Ki-67 (Proliferation) Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies   [ Time Frame: 6 months - baseline ]

4.  Secondary:   Change in Mucosal Apoptosis (Cleaved Caspase-3) as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies   [ Time Frame: 6 months - baseline ]

5.  Secondary:   Change in SNAIL Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies   [ Time Frame: 6 months - baseline ]

6.  Secondary:   Change in E-cadherin Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies   [ Time Frame: 6 months - baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Seema Khan
Organization: Northwestern University
phone: 312-503-4236
e-mail: s-khan2@northwestern.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00828984     History of Changes
Other Study ID Numbers: NCI-2009-01113
NCI-2009-01113 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NCI 06-8-01
CDR0000632553
N01CN35157 ( U.S. NIH Grant/Contract )
NCI06-8-01 ( Other Identifier: Northwestern University )
NWU06-8-01 ( Other Identifier: DCP )
P30CA060553 ( U.S. NIH Grant/Contract )
First Submitted: January 23, 2009
First Posted: January 26, 2009
Results First Submitted: November 18, 2016
Results First Posted: January 19, 2017
Last Update Posted: April 18, 2017