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.
Additional locations may be listed on ClinicalTrials.gov for NCT02598726.
See trial information on ClinicalTrials.gov for a list of participating sites.
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).
CORRELATIVE 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.
Trial PhasePhase I
Trial Typesupportive care
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorAminah Jatoi
