Acupuncture to Reduce Chemotherapy-induced Peripheral Neuropathy Severity During Neoadjuvant or Adjuvant Weekly Paclitaxel Chemotherapy in Breast Cancer Patients: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- CIPN severity as measured by National Cancer Institute-Common Toxicity Criteria version 4.0
研究概览
简要总结
The purpose of this study is to find out the effects of acupuncture on reducing nerve damage.
Acupuncture is a medical technique of inserting very thin needles into the "energy points" on the body with the aim to restore health and well-being. It has been used widely to treat pain, such as lower back pain and joint pain. In this study the investigators will assess if acupuncture can be used to ease the pain, tingling and numbness that may be caused by chemotherapy and improve quality of life during chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Screening Phase:
- •Age 21 or older.
- •Histologically proven stage I-III carcinoma of the breast.
- •Plan to receive adjuvant or neoadjuvant chemotherapy that includes weekly paclitaxel.
- •Eastern Cooperative Oncology Group performance status 0-2 (see Appendix B).
- •The patient is aware of the nature of his/her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
- •Proficiency in English with the ability to speak and read English.
排除标准
- •Known metastatic (stage IV) breast cancer involvement.
- •Pre-existing peripheral neuropathy within 28 days of screening consent
- •Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine, or glutamine.
- •Intervention Phase:
- •Age 21 or older.
- •Histologically proven stage I-III carcinoma of the breast.
- •Receiving adjuvant or neoadjuvant chemotherapy that includes a taxane.
- •Eastern Cooperative Oncology Group performance status 0-2
- •The patient is aware of the nature of his/her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
- •Proficiency in English with the ability to speak and read English
- •While on neurotoxic chemotherapy, has developed NCI-CTC grade 2 CIPN
- •Exclusion Criteria:
- •Known metastatic (stage IV) breast cancer involvement.
- •Pre-existing peripheral neuropathy within 28 days of screening consent.
- •Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine, or glutamine.
结局指标
主要结局
CIPN severity as measured by National Cancer Institute-Common Toxicity Criteria version 4.0
时间窗: 1 year
After the initiation of acupuncture through the end of chemotherapy in breast cancer patients undergoing neoadjuvant or adjuvant weekly paclitaxel chemotherapy when compared to historical control ECOG study 1199 \[1\] weekly paclitaxel treatment arm. The efficacy of acupuncture in reducing CIPN severity and preventing progression of grade 2 CIPN to grade 3 or higher.
次要结局
- CIPN severity as measured by FACT/GOG-Nts(2 years)