Healthy, no Evidence of DiseasePhase 2NCT00365209
Phase II A Trial of Curcumin Among Patients With Prevalent Subclinical Neoplastic Lesions (Aberrant Crypt Foci)
A Phase 2 study testing laboratory biomarker analysis, pharmacological study and curcumin in people with Healthy, no Evidence of Disease and Tobacco Use Disorder, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. Curcumin is a compound found in plants that may prevent colon cancer from forming. This phase II trial is studying how well curcumin works in preventing colon cancer in smokers with aberrant crypt foci. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, no Evidence of Disease, Tobacco Use Disorder
- What is being tested?
- laboratory biomarker analysis, pharmacological study and curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jan 2011
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current smoker with > 3 pack-year total smoking history
- Subjects taking NSAIDS or ASA < 10 days month are eligible but must undergo 14 day washout and refrain from use during the study
- Subjects who are:
- Having a clinically indicated screening/surveillance colonoscopy (e.g. due to risk factors, personal history, or symptoms) OR
- Not having a colonoscopy but are otherwise eligible. These subjects would undergo a flexible sigmoidoscopy.
- ECOG performance status 0-2 (Karnofsky > 60%)
Show all 11Show fewer
- No severe organ dysfunction which might increase bleeding risk:
- Demonstrated by: Normal hematologic status (WBC > 3,000/mm^3, hemoglobin > 10.0 gm/dl, and platelet-count >100,000/mm^3), normal hepatic function (bilirubin < 1.5 mg/dl, transaminases < 1.5x institutional norms), and normal renal function (serum creatinine < 2.0 mg/dl, documented in clinical chart 28 days prior to enrollment
- Healthy current smokers (1 cigarette in previous yr) with > 3-pack year of cigarette smoking and able to provide written informed consent; there are no gender restrictions
- The effects of curcumin on the developing human fetus at the recommended therapeutic dose are unknown; for this reason women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- NSAID or ASA use > 10 days /month; any current glucocorticoid use or omega 3-fatty acid supplement use
- Evidence of the following chronic medical conditions such as:
- Pregnant or lactating women and/or women who are contemplating pregnancy during the duration of the protocol
- History of chronic inflammatory bowel disease or prior pelvic irradiation
- History of peptic ulcer disease (PUD) endoscopically confirmed < 5 yrs from enrollment date
- Newly diagnosed colorectal cancer or advanced adenoma < 1 yr from enrollment
Show all 12Show fewer
- Unspecified history of bleeding or coagulation disorder reported by patient or in medical history
- Hereditary Colon Cancer syndromes (FAP or HNPCC)
- Participants may not be receiving any other investigational agents
- History of contact dermatitis from turmeric
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study because curcumin is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with curcumin, breastfeeding should be discontinued if the mother is treated with curcumin
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 Trial of Curcumin Among Patients With Prevalent Subclinical Neoplastic Lesions (Aberrant Crypt Foci)
Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. Curcumin is a compound found in plants that may prevent colon cancer from forming. This phase II trial is studying how well curcumin works in preventing colon cancer in smokers with aberrant crypt foci.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine mean percentage change from baseline in prostaglandin E2 (PGE2) within ACF pre and post 30 days of curcumin administration at a specified dose.
SECONDARY OBJECTIVS:
- To determine mean percentage change from baseline in 5-hydroxy-eicosatetraenoic acid (5-HETE) within ACF pre and post 30 days of curcumin administration at a specified dose.
II. To determine mean percentage change from baseline in PGE2 and 5-HETE within comparison normal mucosa pre and post 30 days of curcumin administration at a specified dose.
III. To quantify corresponding enzyme changes in the cyclooxygenases (COX-1, COX-2,) and lipoxygenase (5-LOX) protein abundance. Semi-quantitative changes in these proteins will be measured by western blotting and correlated with changes in prostaglandins and leukotrienes respectively.
IV. Document changes in total ACF number. V. Determine proliferation by Ki-67 IHC in rectal mucosa pre and post therapy and correlate with changes in ACF number and size.
VI. Determine curcumin concentration in rectal mucosa after 30 days therapy and correlate with PGE2 and 5-HETE changes described above.
VII. Measure glutathione peroxidase (GPx) activity within the colon pre and post therapy as an indirect marker of reduced oxidative stress within the colonic epithelium.
VIII. Ensure safety of all participants during course of study investigation. IX. Determine the curcumin concentration in plasma before and after treatment.
OUTLINE: This is a multicenter, nonrandomized, uncontrolled study.
Patients receive 1 of 2 doses of oral curcumin once daily. Treatment continues for 30 days in the absence of unacceptable toxicity or disease progression.
Blood and tissue biopsies are obtained by sigmoidoscopy or colonoscopy at baseline and at day 30 for correlative biomarker studies. The change in prostaglandin E_2 (PGE_2) is assessed by enzyme immunoassay, 5-hydroxy-eicosatetraenoic acid (5-HETE) by high-performance liquid chromatography, cyclooxygenases (COX-1 and COX-2) and 5-lipoxygenase (5-LOX) by western blotting, Ki-67 by immunohistochemistry, and glutathione peroxidase (GPx) by spectrophotometric assay.
After completion of study therapy, patients are followed at 1 week.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
- Being tested
- laboratory biomarker analysis, pharmacological study, curcumin
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
Correlative studies
Also called pharmacological studies
Correlative studies
curcuminDrug
Also called C.I. 75300, C.I. Natural Yellow 3, CU, Diferuloylmethane
Given orally
| Study group | Role | What they receive |
|---|---|---|
| 2g (curcumin) | Experimental | Patients receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression. Receives: Other: laboratory biomarker analysis; Other: pharmacological study; Drug: curcumin |
| 4g (curcumin) | Experimental | Patients receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression. Receives: Other: laboratory biomarker analysis; Other: pharmacological study; Drug: curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline in Prostaglandin E2 (PGE2) Within Aberrant Crypt Foci (ACF)
Baseline prostaglandin E2 (PGE2) values found in rectal aberrant crypt foci (ACF) tissue
Measured: Baseline
Post-treatment in Prostaglandin E2 (PGE2) Within Aberrant Crypt Foci (ACF)
Post-treatment prostaglandin E2 (PGE2) values found in rectal aberrant crypt foci (ACF) tissue
Measured: At 30 day
Secondary outcomes (23)
Baseline in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Within Aberrant Crypt Foci (ACF)
Baseline 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in rectal aberrant crypt foci (ACF) tissue
Measured: Baseline
Post-treatment in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Within Aberrant Crypt Foci (ACF)
Post-treatment 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in rectal aberrant crypt foci (ACF) tissue
Measured: At 30 Day
Baseline in Prostaglandin E2 (PGE2) Level in Normal Mucosa
Baseline prostaglandin E2 (PGE2) values found in normal mucosa rectal tissue
Measured: Baseline
Post-treatment in Prostaglandin E2 (PGE2) Level in Normal Mucosa
Post-treatment prostaglandin E2 (PGE2) values found in normal mucosa rectal tissue
Measured: At 30 day
Baseline in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Level in Normal Mucosa
Baseline 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in normal mucosa rectal tissue
Measured: Baseline
Post-treatment in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Level in Normal Mucosa
Post-treatment 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in normal mucosa rectal tissue
Measured: At 30 day
Change in Cyclooxygenases (COX-1, COX-2), and Lipoxygenase (5-LOX) Protein Abundance
The protein levels for each enzyme will be expressed as an absolute change from baseline and graphed against % change of its enzyme product in the same individual. The degree of correlation between these parameters will be assessed by either Pearson's correlation coefficient or Spearman's rank order correlation coefficient.
Measured: Baseline to 30 days
Changes in Total Aberrant Crypt Foci (ACF) Number
Changes in total aberrant crypt foci (ACF) number = Number of ACF at pre-treatment - Number of ACF at post-treatment
Measured: Baseline to 30 days
Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Proximal Third
Measured: Baseline
Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Proximal Third
Measured: At 30 day
Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Middle Third
Measured: Baseline
Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Middle Third
Measured: At 30 day
Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Distal Third
Measured: Baseline
Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Distal Third
Measured: At 30 day
Baseline Curcumin Concentration in Rectal Mucosa
If detectable in the rectal mucosa, it is predicted that curcumin concentrations and potentially curcumin conjugate concentrations will be associated with reduction in PGE2 and 5-HETE measured from colorectal mucosal biopsies. Pearson correlation coefficients between changes in baseline levels in these 2 parameters and curcumin concentration in rectal mucosa will be calculated. Endpoints may be log transformed as appropriate prior to analysis.
Measured: Baseline
Post-treatment Curcumin Concentration in Rectal Mucosa
If detectable in the rectal mucosa, it is predicted that curcumin concentrations and potentially curcumin conjugate concentrations will be associated with reduction in PGE2 and 5-HETE measured from colorectal mucosal biopsies. Pearson correlation coefficients between changes in baseline levels in these 2 parameters and curcumin concentration in rectal mucosa will be calculated. Endpoints may be log transformed as appropriate prior to analysis.
Measured: At 30 day
Baseline Curcumin Plasma Concentrations
Baseline curcumin conjugate concentrations will be measured directly from the subject's plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.
Measured: Baseline
Post-treatment Curcumin Plasma Concentrations
Baseline curcumin conjugate concentrations will be measured directly from the subject's plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.
Measured: At 30 day
Baseline Curcumin Conjugates Concentration in Rectal Mucosa
If detectable in the rectal mucosa, it is predicted that curcumin concentrations and potentially curcumin conjugate concentrations will be associated with reduction in PGE2 and 5-HETE measured from colorectal mucosal biopsies. Pearson correlation coefficients between changes in baseline levels in these 2 parameters and curcumin concentration in rectal mucosa will be calculated. Endpoints may be log transformed as appropriate prior to analysis.
Measured: Baseline
Post-treatment Curcumin Conjugates Concentration in Rectal Mucosa
If detectable in the rectal mucosa, it is predicted that curcumin concentrations and potentially curcumin conjugate concentrations will be associated with reduction in PGE2 and 5-HETE measured from colorectal mucosal biopsies. Pearson correlation coefficients between changes in baseline levels in these 2 parameters and curcumin concentration in rectal mucosa will be calculated. Endpoints may be log transformed as appropriate prior to analysis.
Measured: At 30 day
Baseline Curcumin Conjugates Plasma Concentrations
Baseline curcumin conjugate concentrations will be measured directly from the subject's plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.
Measured: Baseline
Post-treatment Curcumin Conjugates Plasma Concentrations
Post-treatment curcumin conjugate concentrations will be measured directly from the subject's plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.
Measured: At 30 day
Number of Participants at Each Adverse Event Grade Level
Measured: Baseline to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startOct 2006
- Primary completionSep 2008
- Study completionJan 2011
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.
- Other trials for Healthy, no Evidence of DiseaseStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Frank Meyskens, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365209
- Sponsor's protocol ID
- NCI-2013-00449
- Other IDs
- NCI-2013-00449, UIC-2005-0617, CDR0000483003, UCIRVINE-2005-4586, UIC HS# 2005-0617, CCUM-HUM00000731, P30CA062203, 2005-0617
- Status last verified
- Mar 2014
- First submitted
- 16 Aug 2006
- Last updated
- 27 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIA Trial of Curcumin Among Patients With Prevalent Subclinical Neoplastic Lesions (Aberrant Crypt Foci)
- ClinicalTrials.gov ID
- NCT00365209
- Acronym / sponsor ID
- NCI-2013-00449
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Oct 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 17 Aug 2006 (estimated)
- Results
- Posted 27 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. Curcumin is a compound found in plants that may prevent colon cancer from forming. This phase II trial is studying how well curcumin works in preventing colon cancer in smokers with aberrant crypt foci.
Detailed description
PRIMARY OBJECTIVES:
- To determine mean percentage change from baseline in prostaglandin E2 (PGE2) within ACF pre and post 30 days of curcumin administration at a specified dose.
SECONDARY OBJECTIVS:
- To determine mean percentage change from baseline in 5-hydroxy-eicosatetraenoic acid (5-HETE) within ACF pre and post 30 days of curcumin administration at a specified dose.
II. To determine mean percentage change from baseline in PGE2 and 5-HETE within comparison normal mucosa pre and post 30 days of curcumin administration at a specified dose.
III. To quantify corresponding enzyme changes in the cyclooxygenases (COX-1, COX-2,) and lipoxygenase (5-LOX) protein abundance. Semi-quantitative changes in these proteins will be measured by western blotting and correlated with changes in prostaglandins and leukotrienes respectively.
IV. Document changes in total ACF number. V. Determine proliferation by Ki-67 IHC in rectal mucosa pre and post therapy and correlate with changes in ACF number and size.
VI. Determine curcumin concentration in rectal mucosa after 30 days therapy and correlate with PGE2 and 5-HETE changes described above.
VII. Measure glutathione peroxidase (GPx) activity within the colon pre and post therapy as an indirect marker of reduced oxidative stress within the colonic epithelium.
VIII. Ensure safety of all participants during course of study investigation. IX. Determine the curcumin concentration in plasma before and after treatment.
OUTLINE: This is a multicenter, nonrandomized, uncontrolled study.
Patients receive 1 of 2 doses of oral curcumin once daily. Treatment continues for 30 days in the absence of unacceptable toxicity or disease progression.
Blood and tissue biopsies are obtained by sigmoidoscopy or colonoscopy at baseline and at day 30 for correlative biomarker studies. The change in prostaglandin E_2 (PGE_2) is assessed by enzyme immunoassay, 5-hydroxy-eicosatetraenoic acid (5-HETE) by high-performance liquid chromatography, cyclooxygenases (COX-1 and COX-2) and 5-lipoxygenase (5-LOX) by western blotting, Ki-67 by immunohistochemistry, and glutathione peroxidase (GPx) by spectrophotometric assay.
After completion of study therapy, patients are followed at 1 week.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2g (curcumin) | Experimental | Other: laboratory biomarker analysis, Other: pharmacological study, Drug: curcuminPatients receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression. |
| 4g (curcumin) | Experimental | Other: laboratory biomarker analysis, Other: pharmacological study, Drug: curcuminPatients receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Current smoker with > 3 pack-year total smoking history
- Subjects taking NSAIDS or ASA < 10 days month are eligible but must undergo 14 day washout and refrain from use during the study
- Subjects who are:
- ECOG performance status 0-2 (Karnofsky > 60%)
- No severe organ dysfunction which might increase bleeding risk:
Key exclusion criteria (12 listed)
- NSAID or ASA use > 10 days /month; any current glucocorticoid use or omega 3-fatty acid supplement use
- Evidence of the following chronic medical conditions such as:
- Participants may not be receiving any other investigational agents
- History of contact dermatitis from turmeric
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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 |
|---|---|---|
| laboratory biomarker analysisCorrelative studies | Other | 2g (curcumin), 4g (curcumin) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | 2g (curcumin), 4g (curcumin) |
| curcuminAlso: C.I. 75300, C.I. Natural Yellow 3, CU, DiferuloylmethaneGiven orally | Drug | 2g (curcumin), 4g (curcumin) |
Primary outcome
Baseline in Prostaglandin E2 (PGE2) Within Aberrant Crypt Foci (ACF)
Time frame: Baseline
Baseline prostaglandin E2 (PGE2) values found in rectal aberrant crypt foci (ACF) tissue
Post-treatment in Prostaglandin E2 (PGE2) Within Aberrant Crypt Foci (ACF)
Time frame: At 30 day
Post-treatment prostaglandin E2 (PGE2) values found in rectal aberrant crypt foci (ACF) tissue
23 secondary outcomes
Baseline in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Within Aberrant Crypt Foci (ACF)
Time frame: Baseline
Post-treatment in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Within Aberrant Crypt Foci (ACF)
Time frame: At 30 Day
Baseline in Prostaglandin E2 (PGE2) Level in Normal Mucosa
Time frame: Baseline
Post-treatment in Prostaglandin E2 (PGE2) Level in Normal Mucosa
Time frame: At 30 day
Baseline in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Level in Normal Mucosa
Time frame: Baseline
Post-treatment in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Level in Normal Mucosa
Time frame: At 30 day
Change in Cyclooxygenases (COX-1, COX-2), and Lipoxygenase (5-LOX) Protein Abundance
Time frame: Baseline to 30 days
Changes in Total Aberrant Crypt Foci (ACF) Number
Time frame: Baseline to 30 days
Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Proximal Third
Time frame: Baseline
Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Proximal Third
Time frame: At 30 day
Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Middle Third
Time frame: Baseline
Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Middle Third
Time frame: At 30 day
Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Distal Third
Time frame: Baseline
Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Distal Third
Time frame: At 30 day
Baseline Curcumin Concentration in Rectal Mucosa
Time frame: Baseline
Post-treatment Curcumin Concentration in Rectal Mucosa
Time frame: At 30 day
Baseline Curcumin Plasma Concentrations
Time frame: Baseline
Post-treatment Curcumin Plasma Concentrations
Time frame: At 30 day
Baseline Curcumin Conjugates Concentration in Rectal Mucosa
Time frame: Baseline
Post-treatment Curcumin Conjugates Concentration in Rectal Mucosa
Time frame: At 30 day
Baseline Curcumin Conjugates Plasma Concentrations
Time frame: Baseline
Post-treatment Curcumin Conjugates Plasma Concentrations
Time frame: At 30 day
Number of Participants at Each Adverse Event Grade Level
Time frame: Baseline to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Frank Meyskens 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 laboratory biomarker analysis, pharmacological study and curcumin in people with Healthy, no Evidence of Disease and Tobacco Use Disorder, run by National Cancer Institute (NCI) 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 11 inclusion and 12 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 27 Aug 2015. 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 27 Aug 2015). 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?
Baseline in Prostaglandin E2 (PGE2) Within Aberrant Crypt Foci (ACF) (time frame: Baseline). The study lists 2 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 27 Aug 2015.