Clinical trial NCT02976558: The Influence of TaKeTiNa Music Therapy, Traditional Chinese Acupuncture and Clown Theatrical Performance on Quality of Life and the Therapeutic Process of Patients Undergoing Allogenic Stem Cell Transplantation
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hematological Neoplasm
Graft-Versus-Host Disease
Depression
Stem Cell Transplant Complications
Quality of Life
Leukemia
Keywords: CAM
allogenic Stem Cell Transplantation
Graft-Versus-Host Disease
Depression
Quality of Life
Acupuncture
Traditional chinese Medicine
Integrative medicine
Complementary and Alternative Medicine
Music therapy TaKeTiNa
Clown theatrical performance
Humour
Chemotherapy side effects
Psycho neuro immune system
GvHD
PNEIS
CMV
EBV
holistic medicine
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

In TCM, the acupuncture used to stimulate the self-regulation of the body is accompanied by the regular practice of Qi-Gong or Tai-Qi by the patient to achieve the greatest therapeutic effect between the treatments. This additive component can hardly be realized because of the severely restricted general state of the patients.

In order to mobilize the energy and emotions, this study also implements two further treatment modalities, which are practiced with the patient and which the patient can practice on a daily basis by himself:

TaKeTiNa is a form of music therapy founded by Reinhard Flatischler, in which body, voice and movement are used to develop present consciousness, physical feeling and rhythm skills. It has been used therapeutically for more than 20 years.

Furthermore, the processing of arising emotions needs to be facilitated. Patients undergoing an aSCT are exposed to a deeply invasive and debilitating situation for a period of at least four weeks. Characteristics are social isolation through limited visits as well as confinement to a small room, almost complete loss of the privacy and independence through frequent monitoring and lavation necessary during aSCT. Finally the confrontation with the illness, the side effects of the drug treatment and the possible death. Arising emotions can lead to a blockade in the energy flow of the respective organ according to TCM and can cause illness. Therefore, the introduction of six basic gestures from the clown performance according to the Metzler method (KANA-Institut für Koerperprache Freiburg) is intended to give the patient the opportunity to process his emotions in a playful manner in real time or to communicate them directly to another person without words.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Difference in the Quality of Life of the intervention group compared to the control group
timeFrame: day 1 of study compared to day 90 of study
Secondary outcomes:
measure: Difference in development of GvHD of the intervention group compared to the control group
timeFrame: day 1 of study compared to day 90 of study
measure: Difference in development of fungal infections of the intervention group compared to the control group
timeFrame: day 1 of study compared to day 90 of study
measure: Difference in development of bacterial infections of the intervention group compared to the control group
timeFrame: day 1 of study compared to day 90 of study
measure: Difference in development of viral infections including CMV and EBV of the intervention group compared to the control group
timeFrame: day 1 of study compared to day 90 of study
measure: Difference in Depression of the intervention group compared to the control group
timeFrame: day 1 of study compared to day 90 of study
measure: 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
timeFrame: day 1 of study compared to day 90 of study
measure: 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
timeFrame: day 1 of study compared to day 90 of study
measure: Impact on the development of hematoma and soft tissue infections that need treatment (2nd Amendment)
timeFrame: from day 1 of study to day 90
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University of Erlangen Nuermberg Medical School
state: Bavaria
Study officials:
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