NCT01983982已完成不适用
Effect of Chemotherapy on Pain Sensitivity and Patient-reported Symptoms in Early Stage Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of recruiting patients at chemotherapy initiation
研究概览
简要总结
Many breast cancer survivors report chronic pain that develops or worsens following chemotherapy. The impact of chemotherapy on the development of chronic pain is uncertain. In this proposal, we are studying the impact of chemotherapy on a patient's sensitivity to pain. We are also investigating whether a patient's sensitivity to pain is related to how many symptoms she experiences during treatment.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female gender
- •Histologically proven stage I-III invasive carcinoma of the breast who is planning to receive a standard dose of adjuvant chemotherapy.
- •Surgical resection should be complete at the time of study enrollment.
- •Eastern Cooperative Oncology Group performance status 0-2.
排除标准
- •Average pain over the past 24 hours of 4 or greater on a 0-10 scale.
- •Peripheral sensory neuropathy grade 2 or higher.
- •Personal history of schizophrenia or major depressive disorder, or history of suicidal ideation or attempt within the past 2 years.
- •Thumbnail abnormalities on either hand (such as artificial nails) that are likely to alter pain perception during testing.
- •Pregnant or nursing.
- •No prior chemotherapy for any reason
结局指标
主要结局
Feasibility of recruiting patients at chemotherapy initiation
时间窗: 15 weeks
Feasibility will be measured by the proportion of women who complete the post-chemotherapy assessment among those consenting to participate in the trial.
次要结局
- Association Between Baseline Pain-Pressure Threshold and Development of Chemotherapy-associated Acute Pain(15 weeks)
- Change in Pain Sensitivity in Breast Cancer Patients Associated with Chemotherapy(15 weeks)
研究者
N. Lynn Henry
Assistant Professor of Internal Medicine, Medical School
University of Michigan
研究点 (1)
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