Bladder Spasm, Malignant Neoplasm, Pain, Urinary Urgency
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGCurcumin
Given PO
OTHERLaboratory Biomarker Analysis
Correlative studies
DIETARY_SUPPLEMENTPiperine Extract (Standardized)
Given PO
OTHERQuality-of-Life Assessment
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events, using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 | Up to 1 month post-treatment | 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. |
| Maximum tolerated dose (MTD) of curcumin in combination with piperine | 7 days | The MTD of curcumin in combination with piperine is defined as the highest safely tolerated dose level where at most 1 out of 6 patients experience a dose limiting toxicity (DLT) with the next higher dose having at least 2 patients out of a maximum of 6 patients experiencing a DLT. DLT will be assessed using Common Terminology Criteria for Adverse Events version 4.0. Examined in an exploratory and hypothesis-generating fashion. |
| Optimal biologically active dose for curcumin in combination with piperine extract (standardized) | 7 days | Examined in an exploratory and hypothesis-generating fashion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life (QOL) by means of the USSQ | Baseline to 7 days | Reported descriptively. Graphical methods and descriptive statistics will be used to describe the QOL data at baseline and after treatment. Change in QOL from baseline will be assessed via the paired t-test or non-parametric equivalent (Wilcoxon Signed-Rank test). The questions from the USSQ will be summarized descriptively via frequency tables. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in prostaglandin E2 concentrations | Baseline to 7 days | Graphical methods and descriptive statistics will be used to summarize the prostaglandin E2 concentration data. This will be done overall and by dose level. Changes will be summarized by reporting the mean and median percent change from baseline to post-treatment. Percent and absolute change from baseline will also be assessed using the Wilcoxon Signed-Rank test. Fisher's Exact test will be used for assessing the association between categorical variables and the t-test will be used for comparing prostaglandin E2 concentration data across different patient subgroups of interest. |
Countries
United States
Outcome results
None listed