Rochester, Minnesota 55905


Purpose:

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 summary:

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.


Criteria:

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 - Requires treatment with non-steroidal anti-inflammatory agents that cannot be stopped for one week during study participation - 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


NCT ID:

NCT02598726


Primary Contact:

Principal Investigator
Aminah Jatoi
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55905
United States

Clinical Trials Referral Office
Phone: 855-776-0015

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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