NCT02598726

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Bladder Spasm
• Malignant Neoplasm
• Pain
• Urinary Urgency

Interventions

Type	Name	Description
DRUG	Curcumin	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
DIETARY_SUPPLEMENT	Piperine Extract (Standardized)	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-09-19
• Completion: 2018-09-19
• First posted: 2015-11-06
• Last updated: 2025-04-22

Locations

1 site across 1 country: United States