Ignite Creation Date:
2024-05-06 @ 9:26 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02989129
Status:
WITHDRAWN
Last Update Posted:
2018-04-18
First Post:
2016-12-08
Brief Title:
Trial of Quercetin in the Treatment and Prevention of Chemotherapy-induced Neuropathic Pain in Cancer Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Prospective Open Labeled Pilot Trial of Quercetin in the Treatment and Prevention of Chemotherapy-induced Neuropathic Pain in Cancer Patients
Status:
WITHDRAWN
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
FDA IND Approval
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 participants 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 callquestionnaire should take about 10-15 minutes to complete
End-of-Study Visit
About 7 days after participants 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 approvedThe 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
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 callquestionnaire should take about 10-15 minutes to complete
End-of-Study Visit
About 7 days after participants 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 approvedThe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None