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

NCT02598726 | Completed Phase 1 DMC

• 4 other identifiers: MC1511NCI-2015-01716UG1CA18982315-003188
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Spasm; Malignant Neoplasm; Pain; Urinary Urgency

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change in quality of life (QOL) by means of the USSQ

  Baseline to 7 days

Other Outcomes (1)

• Change in prostaglandin E2 concentrations

  Baseline to 7 days

Study Arms (1)

Supportive care (curcumin, piperine)

EXPERIMENTAL

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.

Drug: Curcumin; Other: Laboratory Biomarker Analysis; Dietary Supplement: Piperine Extract (Standardized); Other: Quality-of-Life Assessment

Interventions

Curcumin DRUG

Given PO

Also known as: C.I. 75300, C.I. Natural Yellow 3, Diferuloylmethane, Turmeric Yellow

Supportive care (curcumin, piperine)

Laboratory Biomarker Analysis OTHER

Correlative studies

Supportive care (curcumin, piperine)

Piperine Extract (Standardized) DIETARY_SUPPLEMENT

Given PO

Also known as: Bioperine, Standardized Piperine Extract

Supportive care (curcumin, piperine)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (curcumin, piperine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Neoplasms; Pain

Interventions

Curcumin; piperine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Aminah Jatoi, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: November 6, 2015
• Study Start: March 1, 2016
• Primary Completion: September 19, 2018
• Study Completion: September 19, 2018
• Last Updated: April 22, 2025

Record last verified: 2024-11

Locations

US (1)