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

• Status: Active, not recruiting
• Trial end date: 2022-03-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Curcumin; Piperine

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