What side effects are associated with this type of intervention?

Common treatments for cancer that aim to reduce inflammation include curcumin and piperine. Curcumin, a compound found in turmeric, is known to decrease inflammation by reducing chemical mediators. Piperine, found in black pepper, enhances the bioavailability of curcumin. Side effects of curcumin are generally mild but can include gastrointestinal issues such as nausea and diarrhea. Piperine can also cause gastrointestinal discomfort and may interact with certain medications by affecting drug metabolism. Broadly, other common cancer treatments like chemotherapy and radiation therapy have more severe side effects, including fatigue, nausea, vomiting, hair loss, and increased risk of infections.

What prior FDA approvals exist?

The FDA has approved various treatments for cancer that focus on reducing inflammation and enhancing the efficacy of other treatments. While specific approvals for curcumin and piperine are not mentioned, other anti-inflammatory agents and bioavailability enhancers have been explored. For instance, NSAIDs like aspirin have been studied for their role in cancer prevention due to their anti-inflammatory properties. Additionally, various chemotherapeutic agents and targeted therapies have been approved to treat different types of cancer, often focusing on reducing tumor growth and enhancing patient outcomes.

What other types of research exist?

Promising alternatives to Curcumin and Piperine for cancer patients include cannabinoids (e.g., nabiximols), fish oil (omega-3 fatty acids), and ginger. These agents have shown potential in reducing inflammation and managing cancer-related symptoms.

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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 below

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I have or had cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking specific medications like EGFR inhibitors or calcium channel blockers.

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I currently have gallbladder inflammation.

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I need to take non-steroidal anti-inflammatory drugs that I can't stop for a week.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 month post-treatment for reporting.

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

Piperine Extract (Standardized)

2016

Completed Phase 1

~10

0 / 5Eligibility criteria met

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.