Bladder SpasmPhase 1NCT02598726
Curcumin and Piperine in Reducing Inflammation for Ureteral Stent-Induced Symptoms in Patients With Cancer
A Phase 1 study testing Curcumin, Laboratory Biomarker Analysis and Piperine Extract (Standardized) in people with Bladder Spasm and Malignant Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Spasm, Malignant Neoplasm, Pain
- What is being tested?
- Curcumin, Laboratory Biomarker Analysis and Piperine Extract (Standardized)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 19 Sep 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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.
- Conditions
- Bladder Spasm, Malignant Neoplasm, Pain, Urinary Urgency
- Being tested
- Curcumin, Laboratory Biomarker Analysis, Piperine Extract (Standardized), Quality-of-Life Assessment
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Also called C.I. 75300, C.I. Natural Yellow 3, Diferuloylmethane, Turmeric Yellow
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
Piperine Extract (Standardized)Dietary supplement
Also called Bioperine, Standardized Piperine Extract
Given PO
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (curcumin, piperine) | Experimental | 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. Receives: Drug: Curcumin; Other: Laboratory Biomarker Analysis; Dietary Supplement: Piperine Extract (Standardized); Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events, using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
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.
Measured: Up to 1 month post-treatment
Maximum tolerated dose (MTD) of curcumin in combination with piperine
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.
Measured: 7 days
Optimal biologically active dose for curcumin in combination with piperine extract (standardized)
Examined in an exploratory and hypothesis-generating fashion.
Measured: 7 days
Secondary outcomes (1)
Change in quality of life (QOL) by means of the USSQ
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.
Measured: Baseline to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study start1 Mar 2016
- Primary completion19 Sep 2018
- Study completion19 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder SpasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Aminah Jatoi, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598726
- Sponsor's protocol ID
- MC1511
- Other IDs
- NCI-2015-01716, MC1511, UG1CA189823, 15-003188
- Status last verified
- Nov 2024
- First submitted
- 14 Oct 2015
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02598726
- Acronym / sponsor ID
- MC1511
- Conditions
- Bladder Spasm, Malignant Neoplasm, Pain, Urinary Urgency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 19 Sep 2018 (actual)
- Study completion
- 19 Sep 2018 (actual)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (curcumin, piperine) | Experimental | Drug: Curcumin, Other: Laboratory Biomarker Analysis, Dietary Supplement: Piperine Extract (Standardized), Other: Quality-of-Life AssessmentPatients receive curcumin PO BID or TID and piperine extract (standardized) PO on days 1-7 in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminAlso: C.I. 75300, C.I. Natural Yellow 3, Diferuloylmethane, Turmeric YellowGiven PO | Drug | Supportive care (curcumin, piperine) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Supportive care (curcumin, piperine) |
| Piperine Extract (Standardized)Also: Bioperine, Standardized Piperine ExtractGiven PO | Dietary supplement | Supportive care (curcumin, piperine) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive care (curcumin, piperine) |
Primary outcome
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.
1 secondary outcome
Change in quality of life (QOL) by means of the USSQ
Time frame: Baseline to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aminah Jatoi, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Curcumin, Laboratory Biomarker Analysis and Piperine Extract (Standardized) in people with Bladder Spasm and Malignant Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.