NCT00860041已完成不适用
Paclitaxel-Associated Acute Pain Syndrome Natural History Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 275
- 主要终点
- Maximum of the worst pain scores from the initiation of paclitaxel therapy (day 1) until day 7 (first week of therapy)
研究概览
简要总结
RATIONALE: Gathering information over time from patients receiving paclitaxel for cancer may help doctors learn more about pain caused by paclitaxel and plan the best treatment.
PURPOSE: This clinical trial is studying acute pain caused by paclitaxel in patients with cancer.
详细描述
OBJECTIVES:
- To describe the incidence and characteristics of and change in pain related to paclitaxel infusions over several courses in patients receiving paclitaxel weekly or every 2-4 weeks with or without neurotoxic chemotherapy.
- To investigate the association between paclitaxel-induced acute pain syndrome symptoms and eventual chemotherapy-induced neuropathy.
- To perform exome-sequencing analysis and identify genetic variants that predict paclitaxel- induced peripheral neuropathy.
- To identify clinical phenotypes associated with paclitaxel toxicity (i.e., acute pain syndrome and neuropathy).
- To explore whether there are any evident differences between results seen in the majority Caucasian population and the minority populations.
OUTLINE: This is a multicenter study. Patients are grouped according to paclitaxel dosing schedule (weekly vs every 2-4 weeks) and concurrent use of neurotoxic agent (yes vs no).
Blood samples are collected at baseline for correlative laboratory studies, including genetic biomarker and polymorphism studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Maximum of the worst pain scores from the initiation of paclitaxel therapy (day 1) until day 7 (first week of therapy)
时间窗: Up to day 7
次要结局
- Rate of other pain therapy use(Up to 12 months)
- Rate of non-prescription pain medication use(Up to 12 months)
- Maximum of the average pain score(Up to 12 months)
- Area under the curve of worst, average, and least pain(Up to 12 months)
- Worst pain reported for the overall week(Up to 12 months)
- Rate of opioid use(Up to 12 months)
- Correlation of the worst pain score for the first dose of therapy with subsequent neuropathy scores(Up to 12 months)
研究者
研究点 (275)
Loading locations...
相似试验
终止
不适用
Role of Biomarkers in Muscle Pain and Joint Pain in Patients With Solid Tumors Receiving PaclitaxelArthralgiaPainUnspecified Adult Solid Tumor, Protocol SpecificNCT01096407Vanderbilt-Ingram Cancer Center5
招募中
1 期
An Open-label, Randomized Cross-over, Pharmacokinetic Study to Determine the Bioavailability, Safety, and Tolerability of Two Consecutive Daily Doses of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel Amendment 1CancerACTRN12614000365662Kinex Pharmaceuticals, Inc.8
招募中
不适用
Predicting Peripheral Neuropathy of Paclitaxel for Gastric CancerChemotherapy-induced Peripheral NeuropathyPaclitaxelRamucirumabGastric CancerNCT06490159City of Hope Medical Center150
已完成
3 期
Study of Paclitaxel in Patients With Ovarian CancerPrimary Peritoneal CancerFallopian Tube CancerEpithelial Ovarian CancerNCT00989131Oasmia Pharmaceutical AB789
招募中
不适用
Clinical Biomarker of Paclitaxel-induced Peripheral NeuropathyChemotherapy-induced Peripheral NeuropathyNCT06430814University of Southern Denmark188