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临床试验/NCT02615678
NCT02615678已完成不适用

Acupuncture for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients- A Case Series

Southern California University of Health Sciences2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Changes in perceived neuropathy as measured by EORTC CIPN-20

研究概览

简要总结

The aim of this study is to collect preliminary data on the effectiveness of acupuncture for the treatment of CIPN in breast cancer patients.

详细描述

Ideally 10 patients experiencing peripheral neuropathy due to chemotherapy from breast cancer treatment will be included in this study.They will receive 16 total acupuncture treatments over 10 weeks including various points based off of research and classical text and scalp acupuncture.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Receiving any treatment to prevent neuropathy 2 weeks prior to the screening
  • Pre-existing peripheral neuropathy due to any other cause than chemotherapy
  • Pre-existing conditions like pregnancy, uncontrolled diabetes, hypertension, cardiovascular disorders, bleeding disorders, depression (BDI > 21)
  • Unwilling to follow the protocol
  • Individuals who are receiving government disability assistance

研究组 & 干预措施

Acupuncture

Experimental

Acupuncture including scalp needling will be applied to selected points based on literature

干预措施: Acupuncture (Device)

结局指标

主要结局

Changes in perceived neuropathy as measured by EORTC CIPN-20

时间窗: At baseline, week 6 (treatment 12) and at week 10 (treatment 16)

This is a 20-item self-report multidimensional CIPN specific scale that measures sensory, motor and autonomic symptoms of a 1-4 Likert scale.

次要结局

  • Changes in quality of life as measured by EORTC QLQ-30(At baseline, week 6 (treatment 12) and at week 10 (treatment 16))
  • Changes in perceived neuropathy as measured by Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG) Questionnaire(At baseline, week 6 (treatment 12) and at week 10 (treatment 16))
  • Changes in perceived neuropathy as measured by Visual Analogue Scale of Pain(At baseline, week 6 (treatment 12) and at week 10 (treatment 16))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sivarama Vinjamury

Professor

Southern California University of Health Sciences

研究点 (2)

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