Prospective Open Labeled Pilot Trial of Quercetin in the Treatment and Prevention of Chemotherapy-induced Neuropathic Pain in Cancer Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 主要终点
- Change in Neuropathic Pain Intensity
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Renal impairment.
- •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.
研究组 & 干预措施
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.
干预措施: Questionnaires (Behavioral)
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.
干预措施: Quercetin (Drug)
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.
干预措施: Questionnaires (Behavioral)
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.
干预措施: Quercetin (Drug)
结局指标
主要结局
Change in Neuropathic Pain Intensity
时间窗: 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).
次要结局
未报告次要终点