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

• Status: Withdrawn
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Quercetin

Criteria

Inclusion Criteria:

1. Patients > 18 years old.

2. Patients starting, undergoing or completed chemotherapy at MD Anderson Cancer Center

3. 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).

4. 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.

5. Patients are on stable dose of any medication

6. 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).

7. Patients able to speak English.

8. Patients able to review, understand, and provide written consent.

9. Patients with an Eastern Cooperative Oncology performance (ECOG) status of 0-2.

Exclusion Criteria:

1. Renal impairment.

2. Pregnancy.

3. Hypersensitivity reaction, anaphylaxis, or any other serious adverse reaction to quercetin or product components.

4. Patients who are enrolled in another Pain Medicine trial.

5. Patients with malabsorption syndrome or resection of the stomach or small bowel.

6. Patients with any condition that precludes use of the study medication as determined by the treating physician.

7. Patients taking Quercetin for other medical reasons.

8. Patients taking Digoxin.