NCT02362087已完成不适用
A Multi-Centre Study to Investigate the Natural History of Taxane Acute Pain Syndrome (TAPS) in Patients Receiving Taxane Chemotherapy for Breast or Prostate Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- The incidence of TAPS
研究概览
简要总结
The purpose of this study is to document what course of action physicians choose for their patients when they develop taxane acute pain syndrome (TAPS) and to identify patients at the greatest risk of TAPS by examining specific human genome markers such as single nucleotide polymorphisms (SNPs) and Copy Number Variations (CNVs) that may explain the genetic (hereditary) component.
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
- •Diagnosed with either invasive breast or prostate cancer (stage I-IV)
- •Age ≥18 years
- •ECOG performance status ≤2
- •Scheduled to receive intravenous taxane-based chemotherapy for either adjuvant or metastatic disease
- •Participants need to have ability to complete questionnaires by themselves or with assistance and have the ability to provide informed written consent
排除标准
- •Concurrent use of any agents to try to prevent or treat neuropathy or TAPS, including gabapentin, glutamine, vitamin B6, and vitamin E.
- •Pre-existing history of peripheral neuropathy greater than grade 1 NCI CTCAE version 4.0 from any cause (chemotherapy, diabetes, alcohol, toxin, hereditary, etc.) other medical conditions that would make study participation unreasonably hazardous
- •Uncontrolled diabetes
- •Medical or psychiatric illness that would interfere with patients' ability to complete the diary
结局指标
主要结局
The incidence of TAPS
时间窗: Every 21 days over 12 weeks
Participant will be asked prior to each taxane chemotherapy if they experienced TAPS and complete quality of life questionnaires
次要结局
- The intervention used to reduced TAPS severity(Every 21 days over 12 weeks)
- The TAPS associated treatment modification(Every 21 days over 12 weeks)
- Collection of whole blood and archived tissue for future SNP analysis(At baseline and at one month from the end of Taxane chemotherapy)
研究者
研究点 (1)
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