Trial of Quercetin in the Treatment and Prevention of Chemotherapy-induced Neuropathic Pain in Cancer Patients

April 16, 2018 updated by: M.D. Anderson Cancer Center

Prospective Open Labeled Pilot Trial of Quercetin in the Treatment and Prevention of Chemotherapy-induced Neuropathic Pain in Cancer Patients

The goal of this clinical research study is to learn about the effectiveness of quercetin in treating and preventing CINP. Researchers also want to learn if quercetin has an effect on participant's quality of life.

Study Overview

Detailed Description

Study Product Administration:

If participant is found to be eligible to take part in this study, participant will take quercetin tablets by mouth 2 times every day for 12 weeks. The study staff will give participant the tablets and additional instructions on how to take the study product.

Length of Participation:

Participant may take quercetin for up to 12 weeks. Participant will no longer be able to take quercetin if the pain symptoms gets worse, if intolerable side effects occur, or if participant is unable to follow study directions.

Study Visits:

Every week, participant will either come to the clinic or a member of the staff will call participant to learn how participant is doing, if participant has had any side effects, and to check that participant is taking quercetin correctly. Participant will also complete a questionnaire about any pain symptoms participant may be having. The call/questionnaire should take about 10-15 minutes to complete.

End-of-Study Visit:

About 7 days after participant's last dose of quercetin, participant will complete the same questionnaires participant completed at screening.

Participation in this study will be over after the end-of-study visit.

This is an investigational study. Quercetin is commercially available as a supplement, but it is not FDA approved.The study doctor can explain how the study product is designed to work.

Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.

Study Type

Interventional

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients > 18 years old.
  2. Patients starting, undergoing or completed chemotherapy at MD Anderson Cancer Center
  3. Any cancer patients who received any of the chemotherapeutic agents listed below and developed neuropathic pain for the treatment cohort; or any cancer patients who have been scheduled to receive any of the chemotherapeutic agents listed below for the preventive cohort. The chemotherapeutic agents include 1) taxanes (paclitaxel, docetaxel), 2) vinca alkaloids (vincristine, vinblastine), 3) platinum agents (cisplatin, carboplatin, oxaliplatin), and 4) others (thalidomide, bortezomib, lenalidomide).
  4. Patients have neuropathic pain intensity of at least 4/10 on numeric rating score (NRS, 0/10 being no pain and 10/10 excruciating pain) for the treatment cohort; or 0/10 on NRS for the preventive cohort.
  5. Patients are on stable dose of any medication
  6. Patients followed at the Pain Medicine department. Patients with normal renal function (Normal values, BUN (blood urea nitrogen): 8 to 20 mg/dL, Creatinine: 0.7 to 1.3 mg/dL).
  7. Patients able to speak English.
  8. Patients able to review, understand, and provide written consent.
  9. Patients with an Eastern Cooperative Oncology performance (ECOG) status of 0-2.

Exclusion Criteria:

  1. Renal impairment.
  2. Pregnancy.
  3. Hypersensitivity reaction, anaphylaxis, or any other serious adverse reaction to quercetin or product components.
  4. Patients who are enrolled in another Pain Medicine trial.
  5. Patients with malabsorption syndrome or resection of the stomach or small bowel.
  6. Patients with any condition that precludes use of the study medication as determined by the treating physician.
  7. Patients taking Quercetin for other medical reasons.
  8. Patients taking Digoxin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Chemotherapy Induced Neuropathic Pain (CINP) Treatment Group

Questionnaires completed at Baseline and at End of Study Visit.

Participants take Quercetin tablets by mouth 2 times every day for 12 weeks.

Questionnaires regarding quality of life, pain level, and related symptoms completed at Baseline and at End of Study Visit.. It should take less than 1 hour to complete these questionnaires.
Other Names:
  • Surveys
500 mg by mouth twice daily (after breakfast and dinner) for 12 weeks during study.
EXPERIMENTAL: Chemotherapy Induced Neuropathic Pain (CINP) Prevention Group

Questionnaires completed at Baseline and at End of Study Visit.

Participants take Quercetin tablets by mouth 2 times every day for 12 weeks.

Questionnaires regarding quality of life, pain level, and related symptoms completed at Baseline and at End of Study Visit.. It should take less than 1 hour to complete these questionnaires.
Other Names:
  • Surveys
500 mg by mouth twice daily (after breakfast and dinner) for 12 weeks during study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Neuropathic Pain Intensity
Time Frame: 12 weeks
Primary endpoint is the change in neuropathic pain intensity during 12 weeks of treatment using the the Douleur Neuropathique en 4 questions (DN4).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Salahadin Abdi, MD, PHD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2018

Primary Completion (ANTICIPATED)

April 1, 2020

Study Completion (ANTICIPATED)

April 1, 2020

Study Registration Dates

First Submitted

December 8, 2016

First Submitted That Met QC Criteria

December 8, 2016

First Posted (ESTIMATE)

December 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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