Clinical trial NCT02598726: Curcumin and Piperine in Reducing Inflammation for Ureteral Stent-Induced Symptoms in Patients With Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bladder Spasm
Malignant Neoplasm
Pain
Urinary Urgency
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-11-06
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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
* 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

Primary outcomes:
measure: Incidence of adverse events, using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
timeFrame: Up to 1 month post-treatment
measure: Maximum tolerated dose (MTD) of curcumin in combination with piperine
timeFrame: 7 days
measure: Optimal biologically active dose for curcumin in combination with piperine extract (standardized)
timeFrame: 7 days
Secondary outcomes:
measure: Change in quality of life (QOL) by means of the USSQ
timeFrame: Baseline to 7 days
Other outcomes:
measure: Change in prostaglandin E2 concentrations
timeFrame: Baseline to 7 days
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Aminah Jatoi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: