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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

 

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Aminah Jatoi, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20163565

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