Pilot Study to Assess Breast Sensation Before and After Breast Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- change in sensory perception score
研究概览
简要总结
The purpose of this study is to establish techniques for evaluating breast cutaneous sensation at baseline and following either lumpectomy or mastectomy for breast cancer.
详细描述
Measuring nerve recovery and breast sensibility has been reported in a limited fashion in the past. A number of studies have assessed patients before and after breast reduction surgery using Semmes-Weinstein monofilaments and found this to be an effective technique. A limited number of studies have been done in patients undergoing mastectomy for breast cancer using these techniques. The main limitation of these existing studies is the lack of prospective measurements before surgery and through time, thus restricting the findings to isolated long-term outcomes. Additionally, no studies have compared patients undergoing mastectomy versus lumpectomy to determine the impact that surgical approach has on breast sensibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with ductal carcinoma in-situ (DCIS) or invasive breast cancer
- •patients that have been offered lumpectomy or mastectomy for surgical treatment
- •patients with a high risk of breast cancer and are pursuing prophylactic mastectomies
排除标准
- •metastatic malignancy of any kind
- •subjects will not have breast surgery as a portion of their breast cancer care
- •between 25 and 65 years old
- •subjects with breast implants or a history of prior breast implants
- •subjects that have had prior breast reduction surgery
- •subjects who have had radiation to one of both breasts in the past
- •subjects who cannot give informed consent
研究组 & 干预措施
Surgery
干预措施: Sensory testing and Biopsy (Procedure)
结局指标
主要结局
change in sensory perception score
时间窗: baseline, time of surgery, 3 months, 6 months
change in sensory perception will be conducted using paired t-tests or Wilcoxon tests
次要结局
未报告次要终点