Colorectal CancerPhase 2NCT00578721
Trial of Aspirin and Arginine Restriction in Colorectal Cancer
A Phase 2 study testing Aspirin in people with Colorectal Cancer, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2008to 26 Nov 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Chao Family Comprehensive Cancer Center
Orange, California, 92868
About this study
Official title: Phase IIA Clinical Biomarker Trial of Aspirin and Arginine Restriction in Colorectal Cancer Patients
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.
- Conditions
- Colorectal Cancer
- Being tested
- Aspirin
- Keywords
- Colorectal cancer, aspirin
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
325 mg taken daily with an arginine-restricted diet
| Study group | Role | What they receive |
|---|---|---|
| 325 mg Aspirin | Experimental | 325 mg aspirin po qd with arginine-restricted diet Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study start24 Sep 2008
- Primary completion26 Nov 2013
- Study completion26 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Zell, University of California, Irvine
- Investigators
- Jason Zell, MD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578721
- Sponsor's protocol ID
- UCI 07-47 HS# 2007-5892
- Status last verified
- Jul 2023
- First submitted
- 18 Dec 2007
- Last updated
- 7 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37046763
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIA Clinical Biomarker Trial of Aspirin and Arginine Restriction in Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT00578721
- Acronym / sponsor ID
- UCI 07-47 HS# 2007-5892
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, aspirin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 24 Sep 2008 (actual)
- Primary completion
- 26 Nov 2013 (actual)
- Study completion
- 26 Nov 2013 (actual)
- First posted
- 21 Dec 2007 (estimated)
- Results
- Posted 26 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 325 mg Aspirin | Experimental | Drug: Aspirin325 mg aspirin po qd with arginine-restricted diet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin325 mg taken daily with an arginine-restricted diet | Drug | 325 mg Aspirin |
Primary outcome
Rectal Tissue Putrescine Reduction
Time frame: 12 weeks
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.
1 secondary outcome
Safety/Toxicity
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37046763Zell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Zell, MD principal investigator
Chao Family Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aspirin in people with Colorectal Cancer, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rectal Tissue Putrescine Reduction (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00578721, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.