Adenomatous PolypsNCT00118989
Curcumin for the Chemoprevention of Colorectal Cancer
A study testing Curcuminoids in people with Adenomatous Polyps, run by University of Pennsylvania at 1 site in United States.
Trial summary
Specific Aims: To determine if curcuminoids modulate cellular proliferation as measured by proliferating cell nuclear antigen (PCNA) in the colorectal mucosa of subjects with previously resected adenomatous colonic polyps. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adenomatous Polyps
- What is being tested?
- Curcuminoids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jul 2012
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age>18
- A diagnosis for colon/rectal polyp resection, polypectomy
- Subjects must be able to have the capacity and must be willing to provide informed consent
- Premenopausal women must be surgically incapable of childbearing or be using a medically acceptable method of contraception (oral contraceptives, diaphragms, condoms with spermicide, IUD, progesterone injection or implant) throughout the entire length of the study
- Men should wear condoms during the duration of the study given the unknown effects of curcumin on sperm viability, fertility
Who cannot join
- Previous or current history of colorectal cancer
- Previous history of Familial Polyposis Syndromes
- Previous history of inflammatory bowel disease
- Previous surgery of the large bowel
- Liver disease defined as AST and ALT>3x upper limit of normal
- Known history of gallstones, biliary colic or serum bilirubin >2.0
Show all 20Show fewer
- Cardiac disease including myocardial infarction, congestive heart failure, arrhythmia
- Renal disease defined as creatinine >1.5
- Hematopoietic disease defined as WBC<4000, platelet count <100,000, hemoglobin<10.0 or coagulation or bleeding disorder
- Significantly impaired gastrointestinal function or absorption
- Peptic ulcer disease
- Active infection including viral, bacterial, atypical or fungal infections of any organ system including HIV
- Previous history of allergy to turmeric, Indian curries, aspirin or NSAIDs
- Pregnant or lactating women
- Dementia or other neurologic or psychiatric disease which may impede the ability to follow the protocol
- Inability to swallow pills
- Prior or concurrent therapy with any herbal or dietary supplement containing curcuminoids
- Concurrent use of anticoagulants or antiplatelets including warfarin, clopidogrel
- Prior or concurrent use of colorectal cancer chemopreventive agents including herbals: Sulindac or other NSAIDs, aspirin, COX-2 inhibitors, 5-aminosalicylate, folate, calcium, or their use within 14 days of enrollment
- Concurrent use of immunosuppressants
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Phase II Double Blind Placebo-Controlled Trial of Curcuminoids' Effect on Cellular Proliferation, Apoptosis and COX-2 Expression in the Colorectal Mucosa of Subjects With Recently Resected Sporadic Adenomatous Polyps
Specific Aims:
- To determine if curcuminoids modulate cellular proliferation as measured by proliferating cell nuclear antigen (PCNA) in the colorectal mucosa of subjects with previously resected adenomatous colonic polyps.
Read more
Hypothesis: Curcuminoids decrease cellular proliferation in the colorectal mucosa of subjects with previously resected sporadic adenomatous colonic polyps.
- To determine if curcuminoids modulate apoptosis, as measured by TUNEL assay, in the colorectal mucosa of subjects with previously resected adenomatous colonic polyps.
Hypothesis: Curcuminoids increase apoptosis in colorectal mucosa of subjects with previously resected sporadic adenomatous colonic polyps.
- To determine if curcuminoids modulate COX-2 expression as measured by immunohistochemical assays in subjects with previously resected adenomatous colonic polyps
Hypothesis: Curcuminoids decrease colorectal mucosa COX-2 expression in subjects with previously resected sporadic adenomatous colonic polyps.
- To determine if curcuminoids modulate COX-2 activity as measured by urinary eicosanoids
Hypothesis: Curcuminoids decrease concentrations of urinary eicosanoids.
- Conditions
- Adenomatous Polyps
- Being tested
- Curcuminoids
- Keywords
- Curcumin, chemoprevention, adenomatous polyps, colorectal cancer
- Medical subject headings
- Adenomatous Polyps, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminoidsDietary supplement
Also called Curcuminoids C3 Complex® (Sabinsa Co.)
Curcuminoids C3 Complex® or placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months
| Study group | Role | What they receive |
|---|---|---|
| PLACEBO | Placebo comparator | placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months Receives: Dietary Supplement: Curcuminoids |
| Curcuminoids C3 Complex® to be taken orally via caps | Experimental | Curcuminoids C3 Complex® or placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months Receives: Dietary Supplement: Curcuminoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellular proliferation and apoptosis in the colonic mucosa
Measured: 4 months
Secondary outcomes (1)
COX-2 expression and activity
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2005 (estimated)
- Study startJul 2005
- Primary completionSep 2010
- Study completionJul 2012
Why it stopped: Could not be completed due to technology problems and cost constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenomatous PolypsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Sponsor
- Investigators
- Carmen E Guerra, M.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118989
- Sponsor's protocol ID
- 802193
- Status last verified
- Apr 2017
- First submitted
- 2 Jul 2005
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Double Blind Placebo-Controlled Trial of Curcuminoids' Effect on Cellular Proliferation, Apoptosis and COX-2 Expression in the Colorectal Mucosa of Subjects With Recently Resected Sporadic Adenomatous Polyps
- ClinicalTrials.gov ID
- NCT00118989
- Acronym / sponsor ID
- 802193
- Conditions
- Adenomatous Polyps
- Keywords
- Curcumin, chemoprevention, adenomatous polyps, colorectal cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Could not be completed due to technology problems and cost constraints
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Jul 2005
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 12 Jul 2005 (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.
Specific Aims:
- To determine if curcuminoids modulate cellular proliferation as measured by proliferating cell nuclear antigen (PCNA) in the colorectal mucosa of subjects with previously resected adenomatous colonic polyps.
Hypothesis: Curcuminoids decrease cellular proliferation in the colorectal mucosa of subjects with previously resected sporadic adenomatous colonic polyps.
- To determine if curcuminoids modulate apoptosis, as measured by TUNEL assay, in the colorectal mucosa of subjects with previously resected adenomatous colonic polyps.
Hypothesis: Curcuminoids increase apoptosis in colorectal mucosa of subjects with previously resected sporadic adenomatous colonic polyps.
- To determine if curcuminoids modulate COX-2 expression as measured by immunohistochemical assays in subjects with previously resected adenomatous colonic polyps
Hypothesis: Curcuminoids decrease colorectal mucosa COX-2 expression in subjects with previously resected sporadic adenomatous colonic polyps.
- To determine if curcuminoids modulate COX-2 activity as measured by urinary eicosanoids
Hypothesis: Curcuminoids decrease concentrations of urinary eicosanoids.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLACEBO | Placebo comparator | Dietary Supplement: Curcuminoidsplacebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months |
| Curcuminoids C3 Complex® to be taken orally via caps | Experimental | Dietary Supplement: CurcuminoidsCurcuminoids C3 Complex® or placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age>18
- A diagnosis for colon/rectal polyp resection, polypectomy
- Subjects must be able to have the capacity and must be willing to provide informed consent
- Premenopausal women must be surgically incapable of childbearing or be using a medically acceptable method of contraception (oral contraceptives, diaphragms, condoms with spermicide, IUD, progesterone injection or implant) throughout the entire length of the study
- Men should wear condoms during the duration of the study given the unknown effects of curcumin on sperm viability, fertility
Key exclusion criteria (20 listed)
- Previous or current history of colorectal cancer
- Previous history of Familial Polyposis Syndromes
- Previous history of inflammatory bowel disease
- Previous surgery of the large bowel
- Liver disease defined as AST and ALT>3x upper limit of normal
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 |
|---|---|---|
| CurcuminoidsAlso: Curcuminoids C3 Complex® (Sabinsa Co.)Curcuminoids C3 Complex® or placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months | Dietary supplement | Curcuminoids C3 Complex® to be taken orally via caps, PLACEBO |
Primary outcome
Cellular proliferation and apoptosis in the colonic mucosa
Time frame: 4 months
1 secondary outcome
COX-2 expression and activity
Time frame: 4 months
Results and safety
The study was stopped early (reason given: Could not be completed due to technology problems and cost constraints). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
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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.
Carmen E Guerra, M.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcuminoids in people with Adenomatous Polyps, run by University of Pennsylvania 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 5 inclusion and 20 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: stopped early, as of the sponsor's last update on 20 Apr 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Could not be completed due to technology problems and cost constraints). Results are not available in the source record.
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?
Cellular proliferation and apoptosis in the colonic mucosa (time frame: 4 months). 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 20 Apr 2017.