Colorectal CancerPhase 1NCT01333917
Curcumin Biomarkers
A Phase 1 study testing Curcumin C3 tablet in people with Colorectal Cancer, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Colorectal cancer is a major problem in the United States and other developed countries. A safe and effective chemopreventive agent could reduce the burden of colorectal neoplasia. Curcumin, is a product that is derived from Curcuma longa. It has been used for thousands of years as a traditional remedy. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Curcumin C3 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jan 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 - 80.
- A willingness to follow the study protocol, as indicated by provision of informed consent to participate
- Good general health
Who cannot join
- Familial colorectal cancer syndromes (e.g. Hereditary Non-Polyposis Colon Cancer, Familial Adenomatous Polyposis)
- Ulcerative colitis or Crohn's disease.
- History of large bowel resection for any reason
- Diagnosed narcotic or alcohol dependence
- Unwillingness to forgo curcumin/turmeric-containing supplements during the trial or consumption of curry/turmeric at meals > 3 times a week.
- Allergy to turmeric/curcumin.
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- Women with childbearing potential who do not agree to practice effective birth control.
- Individuals with creatinine, AST or ALT above 1.5 times the upper limit of normal at baseline.
- Personal or inherited bleeding disorders or therapeutic anti-coagulation with warfarin.
- Women who are pregnant or nursing.
- Individuals who have taken antibiotics within the three months prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Department of Family Medicine
Chapel Hill, North Carolina, 27599
About this study
Official title: Curcumin Chemoprevention of Colorectal Neoplasia
Colorectal cancer is a major problem in the United States and other developed countries. A safe and effective chemopreventive agent could reduce the burden of colorectal neoplasia. Curcumin, is a product that is derived from Curcuma longa. It has been used for thousands of years as a traditional remedy. Curcumin blocks a number of targets involved in tumor initiation, promotion, and progression, and is considered a promising chemopreventive agent. The investigators propose to enroll 40 patients after screening colonoscopy who will have rectal biopsies at baseline and after 4 weeks of curcumin 4 grams per day. The investigators will use microarray analysis to identify genes that are modified by curcumin that could be used as biomarkers in future chemoprevention studies. The study will also evaluate tolerability and toxicity.
- Conditions
- Colorectal Cancer
- Being tested
- Curcumin C3 tablet
- Keywords
- Curcumin, Colorectal Cancer, GWAS
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin C3 tabletDrug
4 grams Curcumin C3 tablet daily x30 days
| Study group | Role | What they receive |
|---|---|---|
| Curcumin | Experimental | 4g Curcumin C3 tablet daily Receives: Drug: Curcumin C3 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression
Change in gene expression
Measured: 30 days
Ribonucleic acid (RNA) level
Transcript level as mRNA copies per cell
Measured: 30 days
Apoptosis
Immunohistochemistry (IHC) signal as intensity and proportion of cells stained
Measured: 30 days
Secondary outcomes (1)
Number of Participants with Adverse Events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startNov 2010
- Primary completionOct 2011
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary N Asher, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333917
- Sponsor's protocol ID
- 10-1524
- Status last verified
- Jan 2013
- First submitted
- 6 Apr 2011
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curcumin Chemoprevention of Colorectal Neoplasia
- ClinicalTrials.gov ID
- NCT01333917
- Acronym / sponsor ID
- 10-1524
- Conditions
- Colorectal Cancer
- Keywords
- Curcumin, Colorectal Cancer, GWAS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 12 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colorectal cancer is a major problem in the United States and other developed countries. A safe and effective chemopreventive agent could reduce the burden of colorectal neoplasia. Curcumin, is a product that is derived from Curcuma longa. It has been used for thousands of years as a traditional remedy. Curcumin blocks a number of targets involved in tumor initiation, promotion, and progression, and is considered a promising chemopreventive agent. The investigators propose to enroll 40 patients after screening colonoscopy who will have rectal biopsies at baseline and after 4 weeks of curcumin 4 grams per day. The investigators will use microarray analysis to identify genes that are modified by curcumin that could be used as biomarkers in future chemoprevention studies. The study will also evaluate tolerability and toxicity.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Curcumin | Experimental | Drug: Curcumin C3 tablet4g Curcumin C3 tablet daily |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 40 - 80.
- A willingness to follow the study protocol, as indicated by provision of informed consent to participate
- Good general health
Key exclusion criteria (11 listed)
- Familial colorectal cancer syndromes (e.g. Hereditary Non-Polyposis Colon Cancer, Familial Adenomatous Polyposis)
- Ulcerative colitis or Crohn's disease.
- History of large bowel resection for any reason
- Diagnosed narcotic or alcohol dependence
- Unwillingness to forgo curcumin/turmeric-containing supplements during the trial or consumption of curry/turmeric at meals > 3 times a week.
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 |
|---|---|---|
| Curcumin C3 tablet4 grams Curcumin C3 tablet daily x30 days | Drug | Curcumin |
Primary outcome
Gene expression
Time frame: 30 days
Change in gene expression
Ribonucleic acid (RNA) level
Time frame: 30 days
Transcript level as mRNA copies per cell
Apoptosis
Time frame: 30 days
Immunohistochemistry (IHC) signal as intensity and proportion of cells stained
1 secondary outcome
Number of Participants with Adverse Events
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
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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.
Gary N Asher, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Curcumin C3 tablet in people with Colorectal Cancer, run by University of North Carolina, Chapel Hill 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 3 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 Feb 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gene expression (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2013.