Tobacco Use Disorder Clinical Trial
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | January 2011 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - 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%) - 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 Exclusion Criteria: - 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 - 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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Chao Family Comprehensive Cancer Center | Orange | California |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Baseline in Prostaglandin E2 (PGE2) Within Aberrant Crypt Foci (ACF) | Baseline prostaglandin E2 (PGE2) values found in rectal aberrant crypt foci (ACF) tissue | Baseline | No |
Primary | 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 | At 30 day | No |
Secondary | 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 | Baseline | No |
Secondary | 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 | At 30 Day | No |
Secondary | Baseline in Prostaglandin E2 (PGE2) Level in Normal Mucosa | Baseline prostaglandin E2 (PGE2) values found in normal mucosa rectal tissue | Baseline | No |
Secondary | Post-treatment in Prostaglandin E2 (PGE2) Level in Normal Mucosa | Post-treatment prostaglandin E2 (PGE2) values found in normal mucosa rectal tissue | At 30 day | No |
Secondary | 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 | Baseline | No |
Secondary | 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 | At 30 day | No |
Secondary | 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. | Baseline to 30 days | No |
Secondary | 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 | Baseline to 30 days | No |
Secondary | Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Proximal Third | Baseline | No | |
Secondary | Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Proximal Third | At 30 day | No | |
Secondary | Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Middle Third | Baseline | No | |
Secondary | Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Middle Third | At 30 day | No | |
Secondary | Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Distal Third | Baseline | No | |
Secondary | Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Distal Third | At 30 day | No | |
Secondary | 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. | Baseline | No |
Secondary | 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. | At 30 day | No |
Secondary | 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. | Baseline | No |
Secondary | 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. | At 30 day | No |
Secondary | 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. | Baseline | No |
Secondary | 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. | At 30 day | No |
Secondary | 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. | Baseline | No |
Secondary | 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. | At 30 day | No |
Secondary | Number of Participants at Each Adverse Event Grade Level | Baseline to 30 days | Yes |
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