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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-01

Study Completion Date

2018-09-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bladder Spasm Malignant Neoplasm Pain Urinary Urgency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Curcumin

Intervention Type DRUG

Given PO

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Piperine Extract (Standardized)

Intervention Type DIETARY_SUPPLEMENT

Given PO

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Interventions

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Curcumin

Given PO

Intervention Type DRUG

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Piperine Extract (Standardized)

Given PO

Intervention Type DIETARY_SUPPLEMENT

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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C.I. 75300 C.I. Natural Yellow 3 Diferuloylmethane Turmeric Yellow Bioperine Standardized Piperine Extract Quality of Life Assessment

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No