Study Using Curcumin and Piperine in Reducing Inflammation for Ureteral Stent-Induced Symptoms

Overview

About this study

Ureteral stents can cause severe symptoms yet are necessary to preserve/improve renal function in patients with malignant ureteral obstruction. Stent-induced symptoms are particularly challenging because the medications commonly used to treat them can spawn unacceptable side effects. These stent-induced symptoms appear to be mediated by prostaglandins, particularly prostaglandin E2. Curcumin, a group of spices derived from turmeric, has been tested in 80+ clinical trials and down-regulates prostaglandin E2 and as well other mediators of inflammation.

We hypothesize that urine prostaglandin E2 can serve as a biologic marker to derive an optimal biological dose of oral curcumin + piperine (the latter improves the bioavailability of the former).

We propose a phase I trial with oral curcumin + piperine in older cancer to derive a safe, optimal biological dose to be tested for stent symptoms in a future randomized phase 2 or 3 cancer cooperative group trial.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Age 18 ≥ years at the time of study registration.
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.
Willingness to provide mandatory 24 hour urine collection samples for research purposes.
Able to swallow supplements.
Registration ≥ 3 days after placement of a new stent or ≥ 1 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 felopidine, nifedipine, verapamil); digoxin or quinidine; codeine or fentanyl; phenytoin, propranolol, rifampin, or theophylline.
History of alcohol abuse.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Aminah Jatoi, M.D.	Closed for enrollment	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Aminah Jatoi, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Clinical Trials