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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 : Recruiting
First Posted : November 6, 2015
Last Update Posted : December 2, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

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.

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

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Primary Completion Date : March 15, 2021
Estimated Study Completion Date : March 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Curcumin
Given PO
Other Names:
  • C.I. 75300
  • C.I. Natural Yellow 3
  • Diferuloylmethane
  • Turmeric Yellow

Other: Laboratory Biomarker Analysis
Correlative studies

Dietary Supplement: Piperine Extract (Standardized)
Given PO
Other Names:
  • Bioperine
  • Standardized Piperine Extract

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Optimal biologically active dose for curcumin in combination with piperine extract (standardized) [ Time Frame: 7 days ]
    Examined in an exploratory and hypothesis-generating fashion.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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
Criteria

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
  • 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

Information from the National Library of Medicine

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


Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Aminah Jatoi         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Aminah Jatoi Mayo Clinic

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT02598726     History of Changes
Other Study ID Numbers: MC1511
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: December 2, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Neoplasms
Curcumin
Piperine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 Enzyme Inhibitors