Trial of Aspirin and Arginine Restriction in Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Aspirin
Intervention description: 325 mg taken daily with an arginine-restricted diet
Intervention MeSH terms: Aspirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Colorectal cancer; aspirin

Summary:

      The purpose of this research study is to understand the effects of oral aspirin taken daily
      with an arginine-restricted diet on certain colorectal cancer biomarkers in treated
      colorectal cancer patients. Patients with colorectal cancer are at high risk for recurrence
      and for development of secondary colorectal cancers in the future. Specific chemicals
      (polyamines, prostaglandins) in the body referred to as biomarkers can be measured to help
      understand a person's risk for developing colorectal cancer. Specific biomarkers associated
      with colorectal cancer have been identified in prior laboratory studies. By measuring these
      predefined biomarkers before and after the study intervention, we can assess how they are
      affected by the intervention, and gain knowledge about their usefulness in colorectal cancer
      patients on clinical trial.

      This study is a Phase IIa clinical biomarker study, using oral aspirin 325 mg taken daily
      with an arginine-restricted diet designed to reduce arginine intake by at least 30% during
      the 12-week study period. The biomarkers will be obtained from patient by performing
      endoscopy (a procedure used to look at the inside of the bowel, rectum and colon) and biopsy
      (taking samples of tissue), phlebotomy (drawing blood), and urine collection. Biopsies are
      done to evaluate changes in tissue content that may relate to early events in colon cancer
      formation. This was the procedure used to diagnose your condition initially. There will be 24
      patients enrolled into this study performed through University of California Irvine Medical
      Center.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be 18-80 years of age with a history of surgically removed colon or
             rectal cancer, and have received treatment for their disease using drugs (adjuvant
             chemotherapy)

          -  Subjects must have colon or rectal cancer with stage I, II, or III disease

          -  Subjects should not have further treatment with radiation therapy. Subjects having
             already received adjuvant (i.e., post-operative) radiation therapy to the colon or
             rectum will be excluded. However, subjects receiving radiation therapy prior to
             surgery for rectal cancer are eligible for enrollment.

          -  Subject's tumor must have been completely removed within the past 12 months, with
             first surveillance colonoscopy anticipated 12 weeks after study treatment start date
             (i.e. one-year after surgical removal).

          -  Subjects must be in good physical status

          -  If subjects are premenopausal and perimenopausal women, they must be using adequate
             birth control methods.

          -  Subjects must have no history of another invasive cancer within 5 years

          -  Subjects must have no further chemotherapy anticipated.

          -  Subjects don't have special dietary requirements or additives. Subjects must not be
             consuming a diet that would preclude taking the study medication.

          -  Subjects must have no concomitant use of calcium supplements (> 520mg/day).

          -  Subjects must have no history of abnormal wound healing or repair, or conditions that
             predispose to the same.

          -  Subjects don't have personal history of colon resection of or inflammatory bowel
             disease.

          -  Subjects must give informed consent via consent form approved by the local Human
             Subjects Committee (Institutional Review Board).

          -  If subjects are taking aspirin 81mg by mouth daily they will be eligible

          -  Subjects must have no history of allergies or adverse reactions to aspirin.

          -  Subjects don't have documented history of gastric/duodenal ulcer within the last 12
             months.

        Exclusion Criteria:

          -  Subjects already received radiation therapy to the colon or rectum.

          -  Subjects adhering to vegetarian diets.

          -  Subjects are pregnant or lactating women.

          -  Subjects are breastfeeding

          -  Subjects are already taking aspirin 325mg by mouth daily.

          -  Subjects are taking combination medication with more than 81mg aspirin.

          -  Subjects are currently being treated for gastric/duodenal ulcer or experiencing
             symptoms at study entry.

          -  Subjects have a history of any medical condition that would place them at risk as a
             result of a blood donation, they will be excluded from the study.

          -  Subjects are taking blood-thinning drugs as warfarin (Coumadin)

          -  Subjects are allergic to fenoprofen, ibuprofen, indomethacin, ketoprofen,
             meclofenamate sodium, naproxen, sulindac, tolmetin, or an orange food coloring known
             as tartrazine.

          -  Subjects have liver damage or severe kidney failure