The Effect of Cryotherapy on Breast Cancer Patients in Kaohsiung Medical University Hospital
试验速览
- 阶段
- 不适用
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Patient neurotoxicity questionnaire (PNQ)
研究概览
简要总结
The goal of this clinical trial is to test the effect of cryotherpay on chemotherapy-induced peripheral neuropathy(CIPN) among Breast Cancer Patients. The main questions of research are:
- Does cryotherapy reduce the incidence of CIPN?
- Does cryotherapy reduce the severity of CIPN and improve the quality of life? Participants will be put on the cold gloves and boots during chemotherapy injection process and total 90 minutes.
If there is a comparison group: Researchers will compare usual care group to make sure if it effects of CIPN.
详细描述
This study is designed as a experiment study. In a medical center and breast ward, a randomized controlled trial was used to evaluate the effect of cryotherapy. Block sampling was adopted, and participants total 94 were included. Patients were randomly assigned to the croytherapy group (n=47) or the usual care group(n=47). Both hands and feet received cryotherapy, and the frequency was once every three weeks. Each cycle was 90-150 minutes, and the cycle was performed 4-8 times. The instrument included EPRTC QLQ-CIPN20, PNQ, and EORTC QLQ-C30. After 12-32 weeks, the cryotherapy received qualitative interviews to collect experience and perceptions. Quantitaitve data were constructed and analyzed with SPSS 20.0 version, and Chi-square test was used to detect the incidence of CIPN after three months. Mixed linear model was used to detect the severity of peripheral neuropathy symptoms and quality of life. Survival analysis was used to compare the occurrence time of peripheral neuropathy events between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
Assessors don't know groups
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Breast cancer stage I-III, first time receive paclitaxel neurotoxic chemotherapy, consciousness clear, able to communicate in Taiwanese or Mandarin
排除标准
- •Insulin depent diabetes, Raynaud's disease, cold urticaria disease, cryoglobulinemia and sclerosing basal cell carcinoma, those diagnosed with mental illness, and those with visual or hearing impairments.
结局指标
主要结局
Patient neurotoxicity questionnaire (PNQ)
时间窗: the day after the fourth chemotherapy
the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious
次要结局
- TNSc(Total Neuropathy Score)(the day after the fourth chemotherapy)
- European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20(the day after the fourth chemotherapy)
- European Organization for the Research and Treatment of Cancer core questionnaire QLQ30(the day after the fourth chemotherapy)