NCT01153282已完成不适用
Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of interviews
研究概览
简要总结
Determine the characteristics of symptoms and functional impairment associated with chemotherapy induced peripheral neuropathy.
详细描述
Taxanes, a type of chemotherapeutic agent prescribed to breast cancer patients, have a known physical side effect of chemotherapy induced peripheral neuropathy (CIPN). The purpose of this qualitative study is to understand the experience and physical functional side effects of taxanes. This is the first of a two phase study. The overall goal is to identify existing objective physical performance measures to assess functional side effects of taxanes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 21-70 years old (Women over 70 are offered chemotherapy less frequently because of their risk benefit ratio. Including them would be a selection bias because of their differential underexposure).
- •Initiated taxane-based chemotherapy in the neoadjuvant, adjuvant, or previously untreated metastatic setting.
- •The range of exposure to taxane-based chemotherapy will include women on active treatment having received two cycles, to women who are within three months of their last infusion.
- •Documented symptoms of CIPN per CTCAE grading criteria (half of sample) or NO symptoms (half of sample) Grade 0 = no CIPN symptoms Grade 1 = mild symptoms Grade 2 = moderate symptoms - prescribed Gabapentin (Neurontin) Grade 3&4= severe symptoms - treated with Gabapentin (Neurontin), treatment plan altered
排除标准
- •Physical disabilities - defined by use of assistive devices to complete functional tasks (wheelchair, crutches, prosthetic limbs) prior to starting chemotherapy.
- •Current exposure to neurotoxic agents (Navelbine, platinums or other taxanes)
- •Pregnancy during chemotherapy treatment
- •Diabetes - diagnosed 3 or more years , or insulin dependent, or with clinically established neuropathy
- •Previous exposure to chemotherapy or radiotherapy
- •HIV positive (high risk for neuropathy)
- •Other neurological diseases, such as Multiple Sclerosis
- •Other pre-existing neuropathy
结局指标
主要结局
Number of interviews
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
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