Curcumin and Piperine in Reducing Inflammation for Ureteral Stent-Induced Symptoms in Patients With Cancer

Phase 1 Pilot Study of Curcumin and Piperine to Derive a Safe, Optimal Biologic Dose for Ureteral Stent-Induced Symptoms in Cancer Patients

This pilot phase I trial studies the side effects and best dose of curcumin when given together with piperine (piperine extract [standardized]) in reducing inflammation for ureteral stent-induced symptoms in patients with cancer. Curcumin is a spice similar to turmeric and works by decreasing the chemical moderators that produce inflammation in the body. Piperine is pepper and works by increasing the amount of curcumin available in the body when taken with curcumin. Giving curcumin together with piperine may reduce inflammation and discomfort from a ureteric stent in older patients with cancer.

Study Overview

• Status: Completed
• Conditions: Pain; Malignant Neoplasm; Urinary Urgency; Bladder Spasm
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Drug: Curcumin; Dietary supplement: Piperine Extract (Standardized)

Detailed Description

PRIMARY OBJECTIVES:

I. To conduct a dose-escalation study with curcumin and piperine to derive a safe, optimal biological dose of this combination in cancer patients.

SECONDARY OBJECTIVES:

I. To describe the grade 2+ toxicities associated with curcumin and piperine. II. To evaluate quality of life associated with this combination by means of the Mayo Modified Urinary Stent Symptom Questionnaire (USSQ).

TERTIARY OBJECTIVES:

I. To characterize the change in urinary prostaglandin E2 concentrations that occur at baseline and then after one week of curcumin + piperine.

OUTLINE: This is a dose-escalation study of curcumin.

Patients receive curcumin orally (PO) twice daily (BID) or thrice daily (TID) and piperine extract (standardized) PO on days 1-7 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 month.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ureteral stent in place at study registration
• Patient reports pain, spasms, or urgency symptoms after stent placement, which are thought to be unrelated to other causes as per the patient or healthcare provider or both (documentation in the medical record is unnecessary)
• Ability to complete English language questionnaires by themselves or with assistance
• After the week-long study treatment, participants must be willing to return to the enrolling institution for a follow-up visit
• Willingness to provide mandatory 24 hour urine collection samples for research purposes
• Able to swallow supplements
• Patient must have either a history of cancer or active cancer
• Registration >= 7 days after placement of a new stent or >= 3 days after a stent exchange
• Willingness to refrain from grapefruit juice for 7 days prior to and for 7 days during the study

Exclusion Criteria:

• Receiving warfarin at registration
• Active cholecystitis
• 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
• History of alcohol abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive care (curcumin, piperine); 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Drug: Curcumin; Given PO; Other Names: C.I. 75300; C.I. Natural Yellow 3; Diferuloylmethane; Turmeric Yellow; Dietary supplement: Piperine Extract (Standardized); Given PO; Other Names: Bioperine; Standardized Piperine Extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events, using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0	Examined in an exploratory and hypothesis-generating fashion. The number and severity of all adverse events (overall, by dose-level, and by tumor type) will be tabulated and summarized in this patient population. The grade 2+ adverse events will also be described and summarized in a similar fashion.	Up to 1 month post-treatment
Maximum tolerated dose (MTD) of curcumin in combination with piperine	The MTD of curcumin in combination with piperine is defined as the highest safely tolerated dose level where at most 1 out of 6 patients experience a dose limiting toxicity (DLT) with the next higher dose having at least 2 patients out of a maximum of 6 patients experiencing a DLT. DLT will be assessed using Common Terminology Criteria for Adverse Events version 4.0. Examined in an exploratory and hypothesis-generating fashion.	7 days
Optimal biologically active dose for curcumin in combination with piperine extract (standardized)	Examined in an exploratory and hypothesis-generating fashion.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life (QOL) by means of the USSQ	Reported descriptively. Graphical methods and descriptive statistics will be used to describe the QOL data at baseline and after treatment. Change in QOL from baseline will be assessed via the paired t-test or non-parametric equivalent (Wilcoxon Signed-Rank test). The questions from the USSQ will be summarized descriptively via frequency tables.	Baseline to 7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in prostaglandin E2 concentrations	Graphical methods and descriptive statistics will be used to summarize the prostaglandin E2 concentration data. This will be done overall and by dose level. Changes will be summarized by reporting the mean and median percent change from baseline to post-treatment. Percent and absolute change from baseline will also be assessed using the Wilcoxon Signed-Rank test. Fisher's Exact test will be used for assessing the association between categorical variables and the t-test will be used for comparing prostaglandin E2 concentration data across different patient subgroups of interest.	Baseline to 7 days

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Aminah Jatoi, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): September 19, 2018
• Study Completion (Actual): September 19, 2018

Study Registration Dates

• First Submitted: October 14, 2015
• First Submitted That Met QC Criteria: November 4, 2015
• First Posted (Estimated): November 6, 2015

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Cytochrome P-450 Enzyme Inhibitors; Curcumin; Piperine
• Other Study ID Numbers: MC1511 (Other Identifier: Mayo Clinic); UG1CA189823 (U.S. NIH Grant/Contract); NCI-2015-01716 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 15-003188 (Other Identifier: Mayo Clinic Institutional Review Board)