Macrogol 3350-based Oral Osmotic Laxative in Preventing Cancer in Patients at Risk of Colorectal Cancer
Condition: Adenomatous Polyp; Colorectal Carcinoma
MeSH terms: Colorectal Neoplasms; Adenomatous Polyps
Intervention: macrogol 3350-based oral osmotic laxative; Placebo; Laboratory Biomarker Analysis
Intervention description: Given PO; Given PO; Correlative studies
Intervention MeSH terms: Laxatives; Polyethylene glycol 3350
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of any size adenoma, known adenoma on present exam, or colon cancer within the
             last 6 years

          -  Scheduled for colonoscopy

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Willingness to forego PEG laxative during the study period; if the patient has been on
             a consistent dose of non-PEG laxative for 90 days prior to study entry, the
             participant may continue those laxatives; participants must agree to restrict
             additional laxative use to the rescue medication (bisacodyl) provided

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (equivalent to
             Karnofsky >= 70%)

          -  Leukocytes >= 3,000/uL

          -  Absolute neutrophil count >= 1,500/uL

          -  Platelets >= 100,000/uL

          -  International normalized ratio (INR) =< 1.5

          -  Total bilirubin =< 1.5 X institutional upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 1.5 X institutional ULN

          -  Estimated glomerular filtration rate (eGFR) > 45

          -  Blood urea nitrogen (BUN) < 40

          -  Women of child-bearing potential must agree to use adequate contraception (hormonal or
             barrier method of birth control; restricting intercourse to a surgically sterilized
             partner; abstinence) for the duration of study participation; should a woman become
             pregnant or suspect she is pregnant while participating in this study, she should
             inform her study physician immediately

          -  If patients are on a dose of cardioprotective aspirin, they must have been on a stable
             dose for three months prior to colonoscopy and agree to remain at that dose for the
             six months duration of the study; in addition, patients must agree to limit
             therapeutic nonsteroidal anti-inflammatory drug (NSAID) use (e.g. pain relief) to no
             more than 30 cumulative days during the six month duration of the trial

        Exclusion Criteria:

          -  Average of > 2 bowel movements per day for the 90 days preceding study entry as
             assessed by self-report at baseline

          -  Average consistency of stools described as watery or loose for the 90 days preceding
             study entry as assessed by self-report at baseline

          -  Systemic chemotherapy for any cancer within 18 months prior to enrollment or evidence
             of active malignant disease

          -  Radiation to the rectum within 24 months prior to enrollment

          -  Polyethylene glycol use within 3 months of enrollment (except as part of colonoscopy
             preparation)

          -  Systemic corticosteroid use

          -  Anticoagulant therapy

          -  Inflammatory bowel disease

          -  Removal of the rectum

          -  Evidence of proctitis (radiation, inflammatory bowel disease [IBD], infectious, etc.)
             by history or endoscopy

          -  Other investigational agent use within 30 days prior to enrollment

          -  History of adverse reactions attributed to compounds of similar chemical or biologic
             composition to polyethylene glycol, bisacodyl or methylene blue

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnancy

          -  Patient must not have used suppository medication or enemas for the three months prior
             to the trial or for the duration of the trial except as directed for colonoscopy or
             flexible sigmoidoscopy procedure bowel preparation