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

Primary Purpose

Polyneuropathies and Other Disorders of the Peripheral Nervous System, Chemotherapy Induced Neuropathic Pain

Status

Withdrawn

Phase

Early Phase 1

Locations

Study Type

Interventional

Intervention

Questionnaires

Quercetin

About this trial

This is an interventional treatment trial for Polyneuropathies and Other Disorders of the Peripheral Nervous System focused on measuring Polyneuropathies and Other Disorders of the Peripheral Nervous System, Chemotherapy Induced Neuropathic Pain, CINP, Quercetin, Questionnaires, Surveys

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients > 18 years old.
Patients starting, undergoing or completed chemotherapy at MD Anderson Cancer Center
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).
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.
Patients are on stable dose of any medication
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).
Patients able to speak English.
Patients able to review, understand, and provide written consent.
Patients with an Eastern Cooperative Oncology performance (ECOG) status of 0-2.

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Chemotherapy Induced Neuropathic Pain (CINP) Treatment Group

Chemotherapy Induced Neuropathic Pain (CINP) Prevention Group

Arm Description

Questionnaires completed at Baseline and at End of Study Visit. Participants take Quercetin tablets by mouth 2 times every day for 12 weeks.

Outcomes

Primary Outcome Measures

Change in Neuropathic Pain Intensity

Primary endpoint is the change in neuropathic pain intensity during 12 weeks of treatment using the the Douleur Neuropathique en 4 questions (DN4).

Secondary Outcome Measures

Full Information

NCT ID

NCT02989129

First Posted

December 8, 2016

Last Updated

April 16, 2018

Sponsor

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT02989129

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Withdrawn

Why Stopped

FDA IND Approval

Study Start Date

April 2018 (Anticipated)

Primary Completion Date

April 2020 (Anticipated)

Study Completion Date

April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polyneuropathies and Other Disorders of the Peripheral Nervous System, Chemotherapy Induced Neuropathic Pain

Keywords

Polyneuropathies and Other Disorders of the Peripheral Nervous System, Chemotherapy Induced Neuropathic Pain, CINP, Quercetin, Questionnaires, Surveys

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chemotherapy Induced Neuropathic Pain (CINP) Treatment Group

Arm Type

Experimental

Arm Description

Questionnaires completed at Baseline and at End of Study Visit. Participants take Quercetin tablets by mouth 2 times every day for 12 weeks.

Arm Title

Chemotherapy Induced Neuropathic Pain (CINP) Prevention Group

Arm Type

Experimental

Arm Description

Questionnaires completed at Baseline and at End of Study Visit. Participants take Quercetin tablets by mouth 2 times every day for 12 weeks.

Intervention Type

Behavioral

Intervention Name(s)

Questionnaires

Other Intervention Name(s)

Surveys

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Quercetin

Intervention Description

500 mg by mouth twice daily (after breakfast and dinner) for 12 weeks during study.

Primary Outcome Measure Information:

Title

Change in Neuropathic Pain Intensity

Description

Primary endpoint is the change in neuropathic pain intensity during 12 weeks of treatment using the the Douleur Neuropathique en 4 questions (DN4).

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients > 18 years old. Patients starting, undergoing or completed chemotherapy at MD Anderson Cancer Center 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). 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. Patients are on stable dose of any medication 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). Patients able to speak English. Patients able to review, understand, and provide written consent. Patients with an Eastern Cooperative Oncology performance (ECOG) status of 0-2. Exclusion Criteria: Renal impairment. Pregnancy. Hypersensitivity reaction, anaphylaxis, or any other serious adverse reaction to quercetin or product components. Patients who are enrolled in another Pain Medicine trial. Patients with malabsorption syndrome or resection of the stomach or small bowel. Patients with any condition that precludes use of the study medication as determined by the treating physician. Patients taking Quercetin for other medical reasons. Patients taking Digoxin.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Salahadin Abdi, MD, PHD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

University of Texas MD Anderson Cancer Center Website

Learn more about this trial

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

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