Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 545
- 试验地点
- 1
- 主要终点
- Risk factors predisposing for persistent pain after breast cancer treatment
研究概览
简要总结
The study is a prospective cohort study following breast cancer patients from before surgery to one year after. The aims of the study are to determine risk factors that predispose to the development of persistent pain.
详细描述
The aim of the study is 1) to determine pre-, intra and post surgical risk factors for persistent pain after breast cancer treatment 2) to examine the prevalence of persistent pain 6 and 12 months after surgery 3) provide a quantitative sensory testing (QST) profile of the patient population, measured pre surgery, 1 week and 12 months after surgery.
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
- •Diagnosed with breast cancer
- •18 years or older
排除标准
- •unable to give written consent
- •unable to understand Danish
- •Previous cosmetic surgery in the breast
- •Previous surgery in ipsilateral breast
- •Bilateral cancer
- •Concomitant corrective surgery on contralateral side
- •Other disease or injury in the nervous system
- •Psychiatric disease
- •Alcohol or drug abuse
结局指标
主要结局
Risk factors predisposing for persistent pain after breast cancer treatment
时间窗: 12 months postoperative
Pre-, intra- and postoperative risk factors predisposing for persistent pain
次要结局
- Prevalence of persistent pain after breast cancer treatment(12 months postoperative)
- Prevalence of sensory disturbances after breast cancer treatment(12 months)
- Acute pain after surgery for breast cancer(1 week postoperative)
- Correlation of persistent pain after breast cancer treatment and damage of the intercostobrachial nerve(12 months)
- Quantitative sensory testing: profile and correlation to persistent pain, sensory disturbances, signs of neuropathic pain, and treatment related factors(12 months)
- QST profile 1 week after surgery for breast cancer(1 week postoperative)
- Genetic markers and the development of persistent pain after breast cancer treatment(12 months postoperative)
- Test-Retest of QST after breast cancer treatment(12 months postoperative)
研究者
Kenneth Geving Andersen
Physician, research fellow
Rigshospitalet, Denmark