- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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
Phase
- Early Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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:
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:
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
Sponsor
Investigators
- Principal Investigator: Salahadin Abdi, MD, PHD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-0287
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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