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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
Must not have
Taking any of the following drugs at the time of study participation: epidermal growth factor receptor inhibitor, topoisomerase 1 inhibitor (camptothecin, irinotecan); buspirone, benzodiazepines, zolpidem, calcium channel blockers (such as felodipine, nifedipine, verapamil); digoxin or quinidine; codeine or fentanyl; phenytoin, propranolol, rifampin, or theophylline
Active cholecystitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 month post-treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial studies the effects of curcumin and piperine in reducing inflammation and discomfort in older cancer patients with ureteral stents. Curcumin, found in turmeric, helps reduce inflammation, while piperine, found in black pepper, helps the body absorb more curcumin. The goal is to find the best dose that is safe and effective.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking specific medications like EGFR inhibitors or calcium channel blockers.
Select...
I currently have gallbladder inflammation.
Select...
I need to take non-steroidal anti-inflammatory drugs that I can't stop for a week.
Select...
I am currently taking warfarin.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Change in quality of life (QOL) by means of the USSQ
Other study objectives
Change in prostaglandin E2 concentrations
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~1070
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common cancer treatments work through various mechanisms to target and eliminate cancer cells. Curcumin, a compound similar to turmeric, reduces inflammation by decreasing chemical mediators, which can help alleviate symptoms and potentially slow cancer progression.
Piperine, derived from pepper, enhances the bioavailability of curcumin, making it more effective. Chemotherapy targets rapidly dividing cells, including cancer cells, but can also affect healthy cells, leading to side effects.
Radiation therapy uses high-energy particles to damage the DNA of cancer cells, causing them to die. Immunotherapy boosts the body's immune system to recognize and attack cancer cells.
Understanding these mechanisms is crucial for cancer patients as it helps in selecting the most appropriate treatment, managing side effects, and improving overall outcomes.
Dietary regulation of P-gp function and expression.
Dietary regulation of P-gp function and expression.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,326 Previous Clinical Trials
3,059,473 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,012,019 Total Patients Enrolled
Aminah Jatoi, M.D.Principal InvestigatorMayo Clinic
9 Previous Clinical Trials
352 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.
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