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临床试验/NCT02510066
NCT02510066Unknown3 期

Efficacy and Mechanisms of Acupuncture for Patients With Advanced Pancreatic Cancer Pain: : a Randomized, Placebo Controlled Trial

Shanghai Cancer Hospital, China1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2015年7月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
发起方
入组人数
62
试验地点
1
主要终点
Pain scores, assessed with numeric rating scale (NRS)

研究概览

简要总结

This study compares the effect of acupuncture and placebo acupuncture on advanced pancreatic cancer pain and then investigates its potential mechanism of peripheral blood.

详细描述

Acupuncture may alleviate abdominal or back pain of patients with advanced pancreatic cancer. Acupuncture participants would receive electroacupuncture on Jiaji (Ex-B2) points for 3 times in a week. Placebo acupuncture participants would receive placebo acupuncture on non-point points for the same period. Pain scores on numeric rating scale (NRS) and blood levels of β-endorphin and nerve growth factor are compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Advanced pancreatic cancer at Ⅲ-Ⅳ stage diagnosed by histological/cytological examination.
  • Pain score of abdominal or back pain ≥3 on a numeric rating scale (NRS) graduated from 0 to
  • Stable dose of analgesics at least 72 hours before randomization.
  • Expected survival time more than 1 month.

排除标准

  • Another cause for abdominal or back pain (such as prolapse of lumbar intervertebral disc, ulcer or other intra-abdominal disorder).
  • Acupuncture treatment in the past.
  • Contraindications for the use of acupuncture (such as severe allergies, bleeding tendency, infectious dermatosis and ulcer or scar at points).
  • Unable to give informed consent.

研究组 & 干预措施

Acupuncture

Experimental

Acupuncture participants would receive electroacupuncture on Jiaji (Ex-B2) points for 3 times in a week.

干预措施: Acupuncture (Device)

Placebo acupuncture

Placebo Comparator

Placebo acupuncture participants would receive placebo acupuncture on non-point points for the same period.

干预措施: Placebo acupuncture (Device)

结局指标

主要结局

Pain scores, assessed with numeric rating scale (NRS)

时间窗: 1 week

次要结局

  • Blood levels of β-endorphin(1 week)
  • Karnofsky performance status (KPS) score(1 week)
  • Blood levels of nerve growth factor(1 week)

研究者

发起方
Shanghai Cancer Hospital, China
申办方类型
Other
责任方
Sponsor

研究点 (1)

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