跳至主要内容
临床试验/NCT02976558
NCT02976558终止不适用

Prospective Open Randomized Monocentric Two-armed Controlled Clinical Trial in Parallel Groups to Investigate the Influence of Complementary Medicine (CAM) Interventions on Quality of Life and The Treatment Process of Patients Undergoing Allogenic Stem Cell Transplantation

University of Erlangen-Nürnberg Medical School2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2016年12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
104
试验地点
2
主要终点
Difference in the Quality of Life of the intervention group compared to the control group

研究概览

简要总结

The allogenic stem cell transplantation (aSCT), the only curative approach for many hematological diseases, often leads to severe diseases or chronic conditions, leaving patients with physical disabilities and severe depression and impacting their quality of life in many cases. These consequences are still not adequately addressed by conventional therapies. In this study, the investigators examine the influence of the three complementary medicine methods (CAM) namely acupuncture according to Traditional Chinese Medicine (TCM), music therapy according to the TaKeTiNa method and the psychological disease processing by theatrical clown performance on the quality of life and the therapy process of patients before and after aSCT.

详细描述

The allogenic stem cell transplantation (aSCT) is still the only curative approach for many hematological diseases. Despite new therapeutic developments in the past few years, the therapy-associated mortality rate is around 20%. Patients develop a Graft versus Host Disease (GvHD) in 30-70% of the cases, some with persistent, severe progression and often complicated by infections. In severe chronic conditions, physical disabilities such as weakness, paralysis, scarred vulnerable skin, and blindness may occur. A significant reduction in the quality of life of these patients including severe depression is the consequence.

The demand of patients for supplementary therapy possibilities in the sense of an integrative, complementary medicine is great. There are indications that complementary methods can help improve the quality of life and reduce the associated side effects. However, there are no scientific studies to clarify the efficacy or safety of such therapies in the aSCT.

In this project, the investigators examine the influence of three complementary medicine methods, namely acupuncture according to Traditional Chinese Medicine (TCM), music therapy according to the TaKeTiNa method and the psychological disease processing by theatrical clown performance, on the quality of life and the therapy process of patients before and after aSCT.

Acupuncture according to TCM is an evidence-based therapy approach with few side effects for many diseases. In the past few years, not only their superiority over placebo treatment, but also the point-specific effect has been shown. Based on the numerous published data on pain, nausea, fatigue and depression, it can be assumed that acupuncture reduces the side effects of drug therapy in aSCT and thus improves the quality of life of patients.

According to TCM, the points influence the flow of the energy (referred to as "Qi") in the body and stimulate its self-regulation. In addition, each organ system associated to a different emotion. The unimpeded flow of the ongoing arising of emotions and body energies is, according to TCM, a prerequisite for the health of the organism.

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
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

  • planned allogenic stem cell transplantation
  • patient mentally and intellectually able to understand and sign the form

排除标准

  • Current enrollment in another intervention study
  • clinical diagnosis of depression by HADS-D score plus drug therapy for depression at the time of enrollment

结局指标

主要结局

Difference in the Quality of Life of the intervention group compared to the control group

时间窗: day 1 of study compared to day 90 of study

Assessment through FACT-G Questionaire

次要结局

  • Difference in development of fungal infections of the intervention group compared to the control group(day 1 of study compared to day 90 of study)
  • Difference in development of bacterial infections of the intervention group compared to the control group(day 1 of study compared to day 90 of study)
  • Difference in development of GvHD of the intervention group compared to the control group(day 1 of study compared to day 90 of study)
  • Difference in development of viral infections including CMV and EBV of the intervention group compared to the control group(day 1 of study compared to day 90 of study)
  • Difference in Depression of the intervention group compared to the control group(day 1 of study compared to day 90 of study)
  • Impact of the diagnosis and therapy according to traditional chinese medicine on the difference in development of Infections of the intervention group compared to the control group(day 1 of study compared to day 90 of study)
  • Impact of the diagnosis and therapy according to traditional chinese medicine on the difference in development of GvHD of the intervention group compared to the control group(day 1 of study compared to day 90 of study)
  • Impact on the development of hematoma and soft tissue infections that need treatment (2nd Amendment)(from day 1 of study to day 90)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Behzad

Dr. med.

University of Erlangen-Nürnberg Medical School

研究点 (2)

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