Bladder Cancer Clinical Trial
Curcumin and Piperine in Reducing Inflammation for Ureteral Stent-Induced Symptoms in Patients With Cancer
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.
Full 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.
Eligibility 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
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There is 1 Location for this study
Rochester Minnesota, 55905, United States
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