Curcumin and Piperine in Reducing Inflammation for Ureteral Stent-Induced Symptoms in Patients With Cancer
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|ClinicalTrials.gov Identifier: NCT02598726|
Recruitment Status : Active, not recruiting
First Posted : November 6, 2015
Last Update Posted : August 4, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Bladder Spasm Malignant Neoplasm Pain Urinary Urgency||Drug: Curcumin Other: Laboratory Biomarker Analysis Dietary Supplement: Piperine Extract (Standardized) Other: Quality-of-Life Assessment||Phase 1|
I. To conduct a dose-escalation study with curcumin and piperine to derive a safe, optimal biological dose of this combination in cancer patients.
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).
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Phase 1 Pilot Study of Curcumin and Piperine to Derive a Safe, Optimal Biologic Dose for Ureteral Stent-Induced Symptoms in Cancer Patients|
|Actual Study Start Date :||March 1, 2016|
|Actual Primary Completion Date :||November 6, 2019|
|Estimated Study Completion Date :||July 15, 2023|
Experimental: Supportive care (curcumin, piperine)
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.
Other: Laboratory Biomarker Analysis
Dietary Supplement: Piperine Extract (Standardized)
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
- Incidence of adverse events, using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 7 days ]Examined in an exploratory and hypothesis-generating fashion.
- Change in quality of life (QOL) by means of the USSQ [ Time Frame: 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.
- Change in prostaglandin E2 concentrations [ Time Frame: 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02598726
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Aminah Jatoi||Mayo Clinic|
|Responsible Party:||Mayo Clinic|
|Other Study ID Numbers:||
NCI-2015-01716 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC1511 ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
|First Posted:||November 6, 2015 Key Record Dates|
|Last Update Posted:||August 4, 2022|
|Last Verified:||August 2022|
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