Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Curcumin and Piperine in Reducing Inflammation for Ureteral Stent-Induced Symptoms in Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02598726
Recruitment Status : Recruiting
First Posted : November 6, 2015
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Tracking Information
First Submitted Date  ICMJE October 14, 2015
First Posted Date  ICMJE November 6, 2015
Last Update Posted Date April 8, 2019
Actual Study Start Date  ICMJE March 1, 2016
Estimated Primary Completion Date March 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 4, 2015)
  • 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.
Change History Complete list of historical versions of study NCT02598726 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2016)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2015)
Change in quality of life (QOL) by means of the USSQ [ Time Frame: Baseline to up 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.
Current Other Pre-specified Outcome Measures
 (submitted: June 8, 2016)
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.
Original Other Pre-specified Outcome Measures
 (submitted: November 4, 2015)
Change in prostaglandin E2 concentrations [ Time Frame: Baseline to up 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.
 
Descriptive Information
Brief Title  ICMJE Curcumin and Piperine in Reducing Inflammation for Ureteral Stent-Induced Symptoms in Patients With Cancer
Official Title  ICMJE Phase 1 Pilot Study of Curcumin and Piperine to Derive a Safe, Optimal Biologic Dose for Ureteral Stent-Induced Symptoms in Cancer Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Bladder Spasm
  • Malignant Neoplasm
  • Pain
  • Urinary Urgency
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: Curcumin
  • Other: Laboratory Biomarker Analysis
  • Dietary Supplement: Piperine Extract (Standardized)
  • Other: Quality-of-Life Assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 15, 2021
Estimated Primary Completion Date March 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02598726
Other Study ID Numbers  ICMJE MC1511
NCI-2015-01716 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC1511 ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Aminah Jatoi Mayo Clinic
PRS Account Mayo Clinic
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP