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Dietary Supplement
Curcumin + Piperine for Cancer-Related Inflammation
Phase 1
Waitlist Available
Led By Aminah Jatoi, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must have either a history of cancer or active cancer
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 month post-treatment
Awards & highlights
Study Summary
This trial is testing the effects of curcumin and piperine, a pepper extract, on reducing inflammation from ureteral stents in cancer patients.
Who is the study for?
This trial is for older cancer patients with a ureteral stent who experience pain, spasms, or urgency. They must be able to swallow supplements, avoid grapefruit juice for the study duration, and provide urine samples. It's not suitable for those on warfarin, with active cholecystitis, needing certain anti-inflammatory drugs, or taking specific medications like benzodiazepines.Check my eligibility
What is being tested?
The trial tests if curcumin (a spice) and piperine (from pepper), when taken together can reduce inflammation and discomfort caused by ureteral stents in cancer patients. The study will also determine the best dose of these substances and monitor their effects through questionnaires and urine tests.See study design
What are the potential side effects?
Potential side effects may include digestive issues due to curcumin and piperine ingestion. Since this is a phase I trial determining the best dose, exact side effects are being studied but could involve stomach upset or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have or had cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 month post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 month post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events, using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Maximum tolerated dose (MTD) of curcumin in combination with piperine
Optimal biologically active dose for curcumin in combination with piperine extract (standardized)
Secondary outcome measures
Change in quality of life (QOL) by means of the USSQ
Other outcome measures
Change in prostaglandin E2 concentrations
Trial Design
1Treatment groups
Experimental Treatment
Group I: Supportive care (curcumin, piperine)Experimental Treatment4 Interventions
Patients receive curcumin PO BID or TID and piperine extract (standardized) PO on days 1-7 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Curcumin
2017
Completed Phase 4
~1050
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,131 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,480 Total Patients Enrolled
Aminah Jatoi, M.D.Principal InvestigatorMayo Clinic
9 Previous Clinical Trials
390 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to return for a follow-up after the study treatment.I have or had cancer.It has been over a week since I got a new stent or over 3 days since my last stent was replaced.I experience pain, spasms, or urgency after stent placement not caused by other conditions.I am currently taking specific medications like EGFR inhibitors or calcium channel blockers.I currently have gallbladder inflammation.I need to take non-steroidal anti-inflammatory drugs that I can't stop for a week.I am currently taking warfarin.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive care (curcumin, piperine)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA greenlighted Curcumin for medicinal use?
"Because the available data on Curcumin's safety and effectiveness is limited, it received a score of 1."
Answered by AI
How many participants are currently enrolled in this trial?
"This clinical trial has closed its recruitment period. Initially posted on March 1st 2016, it was last updated August 3rd 2022. If you are seeking alternative studies, there are currently 2717 trials for cancer and 17 other active studies for Curcumin open to volunteers."
Answered by AI
Are there any open opportunities for individuals to participate in this experiment?
"Data posted on clinicaltrials.gov reveals that this medical trial, first published in March of 2016 and last updated in August 2022 is not currently enrolling participants. Despite that, other 2734 studies are still recruiting patients at present moment."
Answered by AI
Have any other investigations probed the potential of Curcumin?
"Currently, there are 17 clinical studies underway for Curcumin with 3 of them in the final stage. The majority of the trials occur in Iowa City, however 21 locations across the US are conducting research on this compound."
Answered by AI
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