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临床试验/NCT01408212
NCT01408212终止不适用

Effectiveness of Additional Acupuncture Therapy for Lung Cancer Patients

Korean Medicine Hospital of Pusan National University2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2011年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
11
试验地点
2
主要终点
Change score of Functional Assessment of Cancer Therapy-Lung (FACT-L) scale from baseline

研究概览

简要总结

This study aims for evaluating the effectiveness, safety and feasibility of additional acupuncture therapy for lung cancer patients who are under chemotherapy in an inpatient setting. The acupuncture therapy will be administered during a resting period between cycles of 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
Supportive Care
盲法
None

入排标准

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

入选标准

  • At least 18 years of age
  • Karnofsky Performance Status (KPS) 60% or more
  • Undergoing antineoplastic chemotherapy for lung cancer
  • Able to provide informed consent

排除标准

  • Brain metastasis, stroke or major psychiatric diseases
  • Active infection
  • Severe heart disease
  • Serious systemic diseases such as uncontrolled hypertension and diabetes mellitus
  • Acupuncture therapy within the previous three months
  • Communication disorder
  • Unwillingness to participate in the trial
  • Severe immunocompromised state (absolute neutrophils count < 1000/cubic mm)

结局指标

主要结局

Change score of Functional Assessment of Cancer Therapy-Lung (FACT-L) scale from baseline

时间窗: 7-10 days during a rest period between chemotherapy cycles

次要结局

  • Change score of Functional Assessment of Cancer Therapy-Lung (FACT-L) scale from baseline(4-5 weeks from baseline (3-4 weeks after treatment termination))
  • Change score of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT fatigue) Scale from baseline(Baseline, 7-10 days after baseline, 4-5 weeks after baseline)
  • Change of general condition assessment using visual analogue scale from baseline(Baseline, 7-10 days after baseline, 4-5 weeks after baseline)
  • Adverse events(From study enrollment to the last follow-up (a maximum of day 36))

研究者

发起方
Korean Medicine Hospital of Pusan National University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jun-Yong Choi

Associate professor

Korean Medicine Hospital of Pusan National University

研究点 (2)

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