Polyneuropathies and Other Disorders of the Peripheral Nervous SystemEarly Phase 1NCT02989129
Trial of Quercetin in the Treatment and Prevention of Chemotherapy-induced Neuropathic Pain in Cancer Patients
A Early Phase 1 study testing Questionnaires and Quercetin in people with Polyneuropathies and Other Disorders of the Peripheral Nervous System and Chemotherapy Induced Neuropathic Pain, run by M.D. Anderson Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyneuropathies and Other Disorders of the Peripheral Nervous System, Chemotherapy Induced Neuropathic Pain
- What is being tested?
- Questionnaires and Quercetin
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Apr 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
About this study
Official title: Prospective Open Labeled Pilot Trial of Quercetin in the Treatment and Prevention of Chemotherapy-induced Neuropathic Pain in Cancer Patients
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.
Read the 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
- Being tested
- Questionnaires, Quercetin
- Keywords
- Polyneuropathies and Other Disorders of the Peripheral Nervous System, Chemotherapy Induced Neuropathic Pain, CINP, Quercetin, Questionnaires, Surveys
- Medical subject headings
- Polyneuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Also called Surveys
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.
QuercetinDrug
500 mg by mouth twice daily (after breakfast and dinner) for 12 weeks during study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Questionnaires; Drug: Quercetin |
| 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. Receives: Behavioral: Questionnaires; Drug: Quercetin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startApr 2018 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Why it stopped: FDA IND Approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyneuropathies and Other Disorders of the Peripheral Nervous SystemStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salahadin Abdi, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989129
- Sponsor's protocol ID
- 2016-0287
- Status last verified
- Apr 2018
- First submitted
- 8 Dec 2016
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Open Labeled Pilot Trial of Quercetin in the Treatment and Prevention of Chemotherapy-induced Neuropathic Pain in Cancer Patients
- ClinicalTrials.gov ID
- NCT02989129
- Acronym / sponsor ID
- 2016-0287
- Conditions
- 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
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: FDA IND Approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy Induced Neuropathic Pain (CINP) Treatment Group | Experimental | Behavioral: Questionnaires, Drug: QuercetinQuestionnaires 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 | Behavioral: Questionnaires, Drug: QuercetinQuestionnaires completed at Baseline and at End of Study Visit. Participants take Quercetin tablets by mouth 2 times every day for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAlso: SurveysQuestionnaires 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. | Behavioural | Chemotherapy Induced Neuropathic Pain (CINP) Prevention Group, Chemotherapy Induced Neuropathic Pain (CINP) Treatment Group |
| Quercetin500 mg by mouth twice daily (after breakfast and dinner) for 12 weeks during study. | Drug | Chemotherapy Induced Neuropathic Pain (CINP) Prevention Group, Chemotherapy Induced Neuropathic Pain (CINP) Treatment Group |
Primary outcome
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).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salahadin Abdi, MD, PHD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Questionnaires and Quercetin in people with Polyneuropathies and Other Disorders of the Peripheral Nervous System and Chemotherapy Induced Neuropathic Pain, run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neuropathic Pain Intensity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.