Acupuncture for Treatment of Peripheral Neuropathy Induced by Neoadjuvant or Adjuvant Paclitaxel in Early Stage Breast Cancer: a Sham Controlled, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The change the effects of neuropathic pain syndromes management from baseline
研究概览
简要总结
The present study aims to evaluate the effectiveness of acupuncture in the treatment of chemotherapy drug paclitaxel induced peripheral neuropathy in patients with early stage breast cancer
详细描述
Patients with early stage breast cancer (stages I,II,III) who received paclitaxel in neoadjuvant or adjuvant chemotherapy protocol and developed peripheral neuropathy will be randomized to receive true acupuncture (intervention group) vs sham acupuncture (control), once a week, for 8 weeks. The primary outcome is improvement of the symptoms by Neuropathic Pain Symptom Inventory (NPSI) scale (Bouhassira,2004). The secondary outcomes are improvements on Visual analog scale (VAS) and Quality of life by FACT-taxane (Cella, 2003) questionnaire. These scales will be assessed in the Screening visit (baseline), week 4, week 6, week 8 and week 12. The study has duration of 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Sham acupuncture
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years old.
- •Agreed to sign the Informed Consent Term
- •Breast cancer stages I, II and III.
- •Received adjuvant or neoadjuvant chemotherapy containing weekly paclitaxel 80 mg/m
- •Peripheral sensory neuropathy grade 2 and 3 by the "Common Terminology Criteria for Adverse Events" (CTCAE) v5.0
排除标准
- •Previous history of peripheral neuropathy due to other comorbidities.
- •Prior treatment with chemotherapy for cancer other than breast cancer.
- •Use of medications to treat peripheral neuropathy.
- •Metastatic disease.
- •Presence of lymphedema of any degree.
- •History of coagulopathy or full anticoagulation.
- •Previous acupuncture treatment for any indication within the last 90 days.
结局指标
主要结局
The change the effects of neuropathic pain syndromes management from baseline
时间窗: Screening visit (baseline), week 4, week 6, week 8, week 12
Neuropathic Pain Symptom Inventory (NPSI) scale. This tool included 12 items in total: 10 are differential symptoms descriptors and 2 items evaluate spontaneous and paroxysmal spontaneous pain. The verbal numeric scale from zero (no pain) to 10 (worst imaginable pain). Total pain intensity score may be calculated by the sum of 10 descriptors.
次要结局
- Baseline pain intensity change(Screening visit (baseline), week 4, week 6, week 8, week 12)
- Change in side effects associated with taxane treatments from baseline(Screening visit (baseline), week 4, week 6, week 8, week 12)