Curcumin and Piperine in Reducing Inflammation for Ureteral Stent-Induced Symptoms in Patients With Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 40
Summary
- Conditions
- Bladder Spasm
- Malignant Neoplasm
- Pain
- Urinary Urgency
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 a...
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.
Tracking Information
- NCT #
- NCT02598726
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Aminah Jatoi Mayo Clinic
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