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FDA IND Approval
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy Induced Neuropathic Pain (CINP) Treatment Group | Experimental | Questionnaires completed at Baseline and at End of Study Visit. Participants take Quercetin tablets by mouth 2 times every day for 12 weeks. |
|
| Chemotherapy Induced Neuropathic Pain (CINP) Prevention Group | Experimental | Questionnaires completed at Baseline and at End of Study Visit. Participants take Quercetin tablets by mouth 2 times every day for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salahadin Abdi, MD, PHD | M.D. Anderson Cancer Center | Principal Investigator |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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|
| Quercetin | Drug | 500 mg by mouth twice daily (after breakfast and dinner) for 12 weeks during study. |
|
| ID | Term |
|---|---|
| D011115 | Polyneuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D011794 | Quercetin |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D044948 | Flavonols |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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