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Trial of Aspirin and Arginine Restriction in Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aspirin
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring Colorectal cancer, aspirin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chao Family Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

325 mg Aspirin

Arm Description

325 mg aspirin po qd with arginine-restricted diet

Outcomes

Primary Outcome Measures

Rectal Tissue Putrescine Reduction
To demonstrate a > 50% decrease in rectal tissue putrescine levels from baseline in study subjects, as a measure of polyamine reduction in the target tissue of colorectal cancer patients.

Secondary Outcome Measures

Safety/Toxicity
To determine the number and proportion of patients with any grade 1 or greater side effect, using Common Terminology for Adverse Events v4.0 (CTCAE)

Full Information

First Posted
December 18, 2007
Last Updated
July 3, 2023
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT00578721
Brief Title
Trial of Aspirin and Arginine Restriction in Colorectal Cancer
Official Title
Phase IIA Clinical Biomarker Trial of Aspirin and Arginine Restriction in Colorectal Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 24, 2008 (Actual)
Primary Completion Date
November 26, 2013 (Actual)
Study Completion Date
November 26, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal cancer, aspirin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
325 mg Aspirin
Arm Type
Experimental
Arm Description
325 mg aspirin po qd with arginine-restricted diet
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
325 mg taken daily with an arginine-restricted diet
Primary Outcome Measure Information:
Title
Rectal Tissue Putrescine Reduction
Description
To demonstrate a > 50% decrease in rectal tissue putrescine levels from baseline in study subjects, as a measure of polyamine reduction in the target tissue of colorectal cancer patients.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Safety/Toxicity
Description
To determine the number and proportion of patients with any grade 1 or greater side effect, using Common Terminology for Adverse Events v4.0 (CTCAE)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Zell, MD
Organizational Affiliation
Chao Family Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
37046763
Citation
Zell JA, Taylor TH, Albers CG, Carmichael JC, McLaren CE, Wenzel L, Stamos MJ. Phase IIa Clinical Biomarker Trial of Dietary Arginine Restriction and Aspirin in Colorectal Cancer Patients. Cancers (Basel). 2023 Mar 31;15(7):2103. doi: 10.3390/cancers15072103.
Results Reference
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Trial of Aspirin and Arginine Restriction in Colorectal Cancer

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