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BRIEF TITLE: Study of Curcumin and Piperine to Derive a Safe, Optimal Biologic Dose for Ureteral Stent-Induced Symptoms in Cancer Patients

Phase 1 Pilot Study of Curcumin and Piperine to Derive a Safe, Optimal Biologic Dose for Ureteral Stent-Induced Symptoms in Cancer Patients


  • Org Study ID: MC1511
  • Secondary ID: NCI-2015-01716,MC1511,P30CA015083
  • NCT ID: NCT02598726
  • NCT Alias:
  • Sponsor: Mayo Clinic - Other
  • Source: 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.

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.

Overal Status Start Date Phase Study Type
Recruiting Start Date: March 2016 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Incidence of adverse events, using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Primary Outcome 1 - Time Frame: Up to 1 month post-treatment

Primary Outcome 2 - Measure: Maximum tolerated dose (MTD) of curcumin in combination with piperine

Primary Outcome 2 - Time Frame: 7 days

Primary Outcome 3 - Measure: Optimal biologically active dose for curcumin in combination with piperine extract (standardized)

Primary Outcome 3 - Time Frame: 7 days

Condition:

  • Bladder Spasm
  • Malignant Neoplasm
  • Pain
  • Urinary Urgency

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

- 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Aminah Jatoi

Role: Principal Investigator

Affiliation: Mayo Clinic

Location

Facility Status Contact
Mayo Clinic
Rochester, Minnesota 55905
United States
Recruiting Clinical Trials Referral Office
855-776-0015