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

NCT02989129 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: 2016-0287
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 participant's quality of life.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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.

Behavioral: Questionnaires; Drug: Quercetin

Interventions

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.

Also known as: Surveys

Chemotherapy Induced Neuropathic Pain (CINP) Prevention Group; Chemotherapy Induced Neuropathic Pain (CINP) Treatment Group

Quercetin DRUG

500 mg by mouth twice daily (after breakfast and dinner) for 12 weeks during study.

Chemotherapy Induced Neuropathic Pain (CINP) Prevention Group; Chemotherapy Induced Neuropathic Pain (CINP) Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Polyneuropathies

Interventions

Surveys and Questionnaires; Quercetin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Salahadin Abdi, MD, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 12, 2016
• Study Start: April 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 18, 2018

Record last verified: 2018-04