NCT02989129

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

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

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Questionnaires	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.
DRUG	Quercetin	500 mg by mouth twice daily (after breakfast and dinner) for 12 weeks during study.

Timeline

• Start date: 2018-04-01
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2016-12-12
• Last updated: 2018-04-18

Regulatory

• FDA-regulated drug study