Clinical trial · Interventional
Curcumin and Piperine in Reducing Inflammation for Ureteral Stent-Induced Symptoms in Patients With Cancer
Phase 1 Pilot Study of Curcumin and Piperine to Derive a Safe, Optimal Biologic Dose for Ureteral Stent-Induced Symptoms in Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Spasm | — | UNRESOLVED | — |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Pain | — | UNRESOLVED | — |
| Urinary Urgency | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Curcumin | Drug | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Piperine Extract (Standardized) | Dietary Supplement | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (curcumin, piperine)
- description
- Patients receive curcumin PO BID or TID and piperine extract (standardized) PO on days 1-7 in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Curcumin
- Other: Laboratory Biomarker Analysis
- Dietary Supplement: Piperine Extract (Standardized)
- Other: Quality-of-Life Assessment
Primary outcomes (3)
- measure
- Incidence of adverse events, using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
- timeFrame
- Up to 1 month post-treatment
- description
- Examined in an exploratory and hypothesis-generating fashion. The number and severity of all adverse events (overall, by dose-level, and by tumor type) will be tabulated and summarized in this patient population. The grade 2+ adverse events will also be described and summarized in a similar fashion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * 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
References
Publications (0)
Data not yet available