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

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Urinary Urgency; Malignant Neoplasm; Pain; Bladder Spasm

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02598726

UG1CA189823 (U.S. NIH Grant/Contract)

NCI-2015-01716 (Registry Identifier)

MC1511 (Other Identifier)

15-003188 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Supportive care (curcumin, piperine)

Experimental group

Description:

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:

Dietary Supplement: Piperine Extract (Standardized)

Other: Laboratory Biomarker Analysis

Other: Quality-of-Life Assessment

Drug: Curcumin