<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02976558</url>
  </required_header>
  <id_info>
    <org_study_id>CCS Erlangen 0383</org_study_id>
    <nct_id>NCT02976558</nct_id>
  </id_info>
  <brief_title>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</brief_title>
  <acronym>TriCAM</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Erlangen-Nürnberg Medical School</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The allogenic stem cell transplantation (aSCT), the only curative approach for many&#xD;
      hematological diseases, often leads to severe diseases or chronic conditions, leaving&#xD;
      patients with physical disabilities and severe depression and impacting their quality of life&#xD;
      in many cases. These consequences are still not adequately addressed by conventional&#xD;
      therapies. In this study, the investigators examine the influence of the three complementary&#xD;
      medicine methods (CAM) namely acupuncture according to Traditional Chinese Medicine (TCM),&#xD;
      music therapy according to the TaKeTiNa method and the psychological disease processing by&#xD;
      theatrical clown performance on the quality of life and the therapy process of patients&#xD;
      before and after aSCT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The allogenic stem cell transplantation (aSCT) is still the only curative approach for many&#xD;
      hematological diseases. Despite new therapeutic developments in the past few years, the&#xD;
      therapy-associated mortality rate is around 20%. Patients develop a Graft versus Host Disease&#xD;
      (GvHD) in 30-70% of the cases, some with persistent, severe progression and often complicated&#xD;
      by infections. In severe chronic conditions, physical disabilities such as weakness,&#xD;
      paralysis, scarred vulnerable skin, and blindness may occur. A significant reduction in the&#xD;
      quality of life of these patients including severe depression is the consequence.&#xD;
&#xD;
      The demand of patients for supplementary therapy possibilities in the sense of an&#xD;
      integrative, complementary medicine is great. There are indications that complementary&#xD;
      methods can help improve the quality of life and reduce the associated side effects. However,&#xD;
      there are no scientific studies to clarify the efficacy or safety of such therapies in the&#xD;
      aSCT.&#xD;
&#xD;
      In this project, the investigators examine the influence of three complementary medicine&#xD;
      methods, namely acupuncture according to Traditional Chinese Medicine (TCM), music therapy&#xD;
      according to the TaKeTiNa method and the psychological disease processing by theatrical clown&#xD;
      performance, on the quality of life and the therapy process of patients before and after&#xD;
      aSCT.&#xD;
&#xD;
      Acupuncture according to TCM is an evidence-based therapy approach with few side effects for&#xD;
      many diseases. In the past few years, not only their superiority over placebo treatment, but&#xD;
      also the point-specific effect has been shown. Based on the numerous published data on pain,&#xD;
      nausea, fatigue and depression, it can be assumed that acupuncture reduces the side effects&#xD;
      of drug therapy in aSCT and thus improves the quality of life of patients.&#xD;
&#xD;
      According to TCM, the points influence the flow of the energy (referred to as &quot;Qi&quot;) in the&#xD;
      body and stimulate its self-regulation. In addition, each organ system associated to a&#xD;
      different emotion. The unimpeded flow of the ongoing arising of emotions and body energies&#xD;
      is, according to TCM, a prerequisite for the health of the organism.&#xD;
&#xD;
      In TCM, the acupuncture used to stimulate the self-regulation of the body is accompanied by&#xD;
      the regular practice of Qi-Gong or Tai-Qi by the patient to achieve the greatest therapeutic&#xD;
      effect between the treatments. This additive component can hardly be realized because of the&#xD;
      severely restricted general state of the patients.&#xD;
&#xD;
      In order to mobilize the energy and emotions, this study also implements two further&#xD;
      treatment modalities, which are practiced with the patient and which the patient can practice&#xD;
      on a daily basis by himself:&#xD;
&#xD;
      TaKeTiNa is a form of music therapy founded by Reinhard Flatischler, in which body, voice and&#xD;
      movement are used to develop present consciousness, physical feeling and rhythm skills. It&#xD;
      has been used therapeutically for more than 20 years.&#xD;
&#xD;
      Furthermore, the processing of arising emotions needs to be facilitated. Patients undergoing&#xD;
      an aSCT are exposed to a deeply invasive and debilitating situation for a period of at least&#xD;
      four weeks. Characteristics are social isolation through limited visits as well as&#xD;
      confinement to a small room, almost complete loss of the privacy and independence through&#xD;
      frequent monitoring and lavation necessary during aSCT. Finally the confrontation with the&#xD;
      illness, the side effects of the drug treatment and the possible death. Arising emotions can&#xD;
      lead to a blockade in the energy flow of the respective organ according to TCM and can cause&#xD;
      illness. Therefore, the introduction of six basic gestures from the clown performance&#xD;
      according to the Metzler method (KANA-Institut für Koerperprache Freiburg) is intended to&#xD;
      give the patient the opportunity to process his emotions in a playful manner in real time or&#xD;
      to communicate them directly to another person without words.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to organisational issues, the study had to be completed prematurely.&#xD;
  </why_stopped>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">December 16, 2019</completion_date>
  <primary_completion_date type="Actual">December 16, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in the Quality of Life of the intervention group compared to the control group</measure>
    <time_frame>day 1 of study compared to day 90 of study</time_frame>
    <description>Assessment through FACT-G Questionaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in development of GvHD of the intervention group compared to the control group</measure>
    <time_frame>day 1 of study compared to day 90 of study</time_frame>
    <description>Assessment through staging of GvHD and required days of hospitalisation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in development of fungal infections of the intervention group compared to the control group</measure>
    <time_frame>day 1 of study compared to day 90 of study</time_frame>
    <description>Assessment through required days of hospitalisation and antimycotic therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in development of bacterial infections of the intervention group compared to the control group</measure>
    <time_frame>day 1 of study compared to day 90 of study</time_frame>
    <description>Assessment through required days of hospitalisation and antibiotic therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in development of viral infections including CMV and EBV of the intervention group compared to the control group</measure>
    <time_frame>day 1 of study compared to day 90 of study</time_frame>
    <description>Assessment through required days of hospitalisation and antiviral therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in Depression of the intervention group compared to the control group</measure>
    <time_frame>day 1 of study compared to day 90 of study</time_frame>
    <description>Assessment through HADS-D questionaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <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</measure>
    <time_frame>day 1 of study compared to day 90 of study</time_frame>
    <description>Assessment days of hospitalisation and antiinfective therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <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</measure>
    <time_frame>day 1 of study compared to day 90 of study</time_frame>
    <description>Assessment through staging of GvHD and required days of hospitalisation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact on the development of hematoma and soft tissue infections that need treatment (2nd Amendment)</measure>
    <time_frame>from day 1 of study to day 90</time_frame>
    <description>Patients in the intervention group receive acupuncture as one of the three treatment modalities. Any development of hematoma on the skin or any soft tissue infection that need either local treatment (cooling agents, medical ointments etc.) or systemic treatment (surgery or systemic antibiotics) will be documented as an event. Total number of hematomas needing treatment and soft tissue infections needing treatment will be compared between intervention and control group</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Hematological Neoplasm</condition>
  <condition>Graft-Versus-Host Disease</condition>
  <condition>Depression</condition>
  <condition>Stem Cell Transplant Complications</condition>
  <condition>Quality of Life</condition>
  <condition>Leukemia</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Interventions:&#xD;
Acupuncture, music therapy (TaKeTiNa) and Clown theatrical performance starting before allogenic stem cell transplant until three months after transplantation.&#xD;
Interventions each twice a week for 4 weeks, then once a week for 4 weeks, then once every two weeks for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>control group. No interventions</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Clown theatrical Performance</intervention_name>
    <arm_group_label>Treatment Group</arm_group_label>
    <other_name>theatre therapy, humour for health</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <description>Acupuncture according to Traditional Chinese Medicine</description>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Music Therapy TaKeTiNa</intervention_name>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  planned allogenic stem cell transplantation&#xD;
&#xD;
          -  patient mentally and intellectually able to understand and sign the form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current enrollment in another intervention study&#xD;
&#xD;
          -  clinical diagnosis of depression by HADS-D score plus drug therapy for depression at&#xD;
             the time of enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Erlangen Nuermberg Medical School</name>
      <address>
        <city>Erlangen</city>
        <state>Bavaria</state>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Bacigalupo A, Sormani MP, Lamparelli T, Gualandi F, Occhini D, Bregante S, Raiola AM, di Grazia C, Dominietto A, Tedone E, Piaggio G, Podesta M, Bruno B, Oneto R, Lombardi A, Frassoni F, Rolla D, Rollandi G, Viscoli C, Ferro C, Garbarino L, Van Lint MT. Reducing transplant-related mortality after allogeneic hematopoietic stem cell transplantation. Haematologica. 2004 Oct;89(10):1238-47.</citation>
    <PMID>15477210</PMID>
  </reference>
  <reference>
    <citation>Blazar BR, Murphy WJ, Abedi M. Advances in graft-versus-host disease biology and therapy. Nat Rev Immunol. 2012 May 11;12(6):443-58. doi: 10.1038/nri3212.</citation>
    <PMID>22576252</PMID>
  </reference>
  <reference>
    <citation>Braamse AM, Yi JC, Visser OJ, Heymans MW, van Meijel B, Dekker J, Syrjala KL. Developing a Risk Prediction Model for Long-Term Physical and Psychological Functioning after Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant. 2016 Mar;22(3):549-56. doi: 10.1016/j.bbmt.2015.11.1102. Epub 2015 Dec 11.</citation>
    <PMID>26685773</PMID>
  </reference>
  <reference>
    <citation>Fasching PA, Thiel F, Nicolaisen-Murmann K, Rauh C, Engel J, Lux MP, Beckmann MW, Bani MR. Association of complementary methods with quality of life and life satisfaction in patients with gynecologic and breast malignancies. Support Care Cancer. 2007 Nov;15(11):1277-1284. doi: 10.1007/s00520-007-0231-1. Epub 2007 Mar 1.</citation>
    <PMID>17333294</PMID>
  </reference>
  <reference>
    <citation>Garcia MK, McQuade J, Haddad R, Patel S, Lee R, Yang P, Palmer JL, Cohen L. Systematic review of acupuncture in cancer care: a synthesis of the evidence. J Clin Oncol. 2013 Mar 1;31(7):952-60. doi: 10.1200/JCO.2012.43.5818. Epub 2013 Jan 22.</citation>
    <PMID>23341529</PMID>
  </reference>
  <reference>
    <citation>Lee A, Chan SK, Fan LT. Stimulation of the wrist acupuncture point PC6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2015 Nov 2;2015(11):CD003281. doi: 10.1002/14651858.CD003281.pub4.</citation>
    <PMID>26522652</PMID>
  </reference>
  <reference>
    <citation>Shneerson C, Taskila T, Gale N, Greenfield S, Chen YF. The effect of complementary and alternative medicine on the quality of life of cancer survivors: a systematic review and meta-analyses. Complement Ther Med. 2013 Aug;21(4):417-29. doi: 10.1016/j.ctim.2013.05.003. Epub 2013 Jun 3.</citation>
    <PMID>23876573</PMID>
  </reference>
  <reference>
    <citation>Sun CL, Francisco L, Baker KS, Weisdorf DJ, Forman SJ, Bhatia S. Adverse psychological outcomes in long-term survivors of hematopoietic cell transplantation: a report from the Bone Marrow Transplant Survivor Study (BMTSS). Blood. 2011 Oct 27;118(17):4723-31. doi: 10.1182/blood-2011-04-348730. Epub 2011 Aug 5.</citation>
    <PMID>21821714</PMID>
  </reference>
  <reference>
    <citation>Saramago P, Woods B, Weatherly H, Manca A, Sculpher M, Khan K, Vickers AJ, MacPherson H. Methods for network meta-analysis of continuous outcomes using individual patient data: a case study in acupuncture for chronic pain. BMC Med Res Methodol. 2016 Oct 6;16(1):131. doi: 10.1186/s12874-016-0224-1.</citation>
    <PMID>27716074</PMID>
  </reference>
  <reference>
    <citation>Witt CM, Pach D, Brinkhaus B, Wruck K, Tag B, Mank S, Willich SN. Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forsch Komplementmed. 2009 Apr;16(2):91-7. doi: 10.1159/000209315. Epub 2009 Apr 9.</citation>
    <PMID>19420954</PMID>
  </reference>
  <reference>
    <citation>Fuentealba Cargill F, Biagini Alarcon L. [Acupuncture for postoperative pain, a literature review]. Rev Med Chil. 2016 Mar;144(3):325-32. doi: 10.4067/S0034-98872016000300007. Spanish.</citation>
    <PMID>27299818</PMID>
  </reference>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>December 16, 2019</last_update_submitted>
  <last_update_submitted_qc>December 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Erlangen-Nürnberg Medical School</investigator_affiliation>
    <investigator_full_name>Ali Behzad</investigator_full_name>
    <investigator_title>Dr. med.</investigator_title>
  </responsible_party>
  <keyword>CAM</keyword>
  <keyword>allogenic Stem Cell Transplantation</keyword>
  <keyword>Graft-Versus-Host Disease</keyword>
  <keyword>Depression</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Acupuncture</keyword>
  <keyword>Traditional chinese Medicine</keyword>
  <keyword>Integrative medicine</keyword>
  <keyword>Complementary and Alternative Medicine</keyword>
  <keyword>Music therapy TaKeTiNa</keyword>
  <keyword>Clown theatrical performance</keyword>
  <keyword>Humour</keyword>
  <keyword>Chemotherapy side effects</keyword>
  <keyword>Psycho neuro immune system</keyword>
  <keyword>GvHD</keyword>
  <keyword>PNEIS</keyword>
  <keyword>CMV</keyword>
  <keyword>EBV</keyword>
  <keyword>holistic medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Neoplasms</mesh_term>
    <mesh_term>Graft vs Host Disease</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02976558
org study id: CCS Erlangen 0383
nct id: NCT02976558
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Difference in the Quality of Life of the intervention group compared to the control group
time frame: day 1 of study compared to day 90 of study
description: Assessment through FACT-G Questionaire
measure: Difference in development of GvHD of the intervention group compared to the control group
time frame: day 1 of study compared to day 90 of study
description: Assessment through staging of GvHD and required days of hospitalisation
measure: Difference in development of fungal infections of the intervention group compared to the control group
time frame: day 1 of study compared to day 90 of study
description: Assessment through required days of hospitalisation and antimycotic therapy
measure: Difference in development of bacterial infections of the intervention group compared to the control group
time frame: day 1 of study compared to day 90 of study
description: Assessment through required days of hospitalisation and antibiotic therapy
measure: Difference in development of viral infections including CMV and EBV of the intervention group compared to the control group
time frame: day 1 of study compared to day 90 of study
description: Assessment through required days of hospitalisation and antiviral therapy
measure: Difference in Depression of the intervention group compared to the control group
time frame: day 1 of study compared to day 90 of study
description: Assessment through HADS-D questionaire
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
time frame: day 1 of study compared to day 90 of study
description: Assessment days of hospitalisation and antiinfective therapy
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
time frame: day 1 of study compared to day 90 of study
description: Assessment through staging of GvHD and required days of hospitalisation
measure: Impact on the development of hematoma and soft tissue infections that need treatment (2nd Amendment)
time frame: from day 1 of study to day 90
description: Patients in the intervention group receive acupuncture as one of the three treatment modalities. Any development of hematoma on the skin or any soft tissue infection that need either local treatment (cooling agents, medical ointments etc.) or systemic treatment (surgery or systemic antibiotics) will be documented as an event. Total number of hematomas needing treatment and soft tissue infections needing treatment will be compared between intervention and control group
arm group label: Treatment Group
arm group type: Experimental
description: Interventions:
Acupuncture, music therapy (TaKeTiNa) and Clown theatrical performance starting before allogenic stem cell transplant until three months after transplantation.
Interventions each twice a week for 4 weeks, then once a week for 4 weeks, then once every two weeks for 4 weeks
arm group label: Control Group
arm group type: No Intervention
description: control group. No interventions
intervention type: Behavioral
intervention name: Clown theatrical Performance
arm group label: Treatment Group
other name: theatre therapy, humour for health
intervention type: Procedure
intervention name: Acupuncture
description: Acupuncture according to Traditional Chinese Medicine
arm group label: Treatment Group
intervention type: Behavioral
intervention name: Music Therapy TaKeTiNa
arm group label: Treatment Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
citation: Bacigalupo A, Sormani MP, Lamparelli T, Gualandi F, Occhini D, Bregante S, Raiola AM, di Grazia C, Dominietto A, Tedone E, Piaggio G, Podesta M, Bruno B, Oneto R, Lombardi A, Frassoni F, Rolla D, Rollandi G, Viscoli C, Ferro C, Garbarino L, Van Lint MT. Reducing transplant-related mortality after allogeneic hematopoietic stem cell transplantation. Haematologica. 2004 Oct;89(10):1238-47.
PMID: 15477210
citation: Blazar BR, Murphy WJ, Abedi M. Advances in graft-versus-host disease biology and therapy. Nat Rev Immunol. 2012 May 11;12(6):443-58. doi: 10.1038/nri3212.
PMID: 22576252
citation: Braamse AM, Yi JC, Visser OJ, Heymans MW, van Meijel B, Dekker J, Syrjala KL. Developing a Risk Prediction Model for Long-Term Physical and Psychological Functioning after Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant. 2016 Mar;22(3):549-56. doi: 10.1016/j.bbmt.2015.11.1102. Epub 2015 Dec 11.
PMID: 26685773
citation: Fasching PA, Thiel F, Nicolaisen-Murmann K, Rauh C, Engel J, Lux MP, Beckmann MW, Bani MR. Association of complementary methods with quality of life and life satisfaction in patients with gynecologic and breast malignancies. Support Care Cancer. 2007 Nov;15(11):1277-1284. doi: 10.1007/s00520-007-0231-1. Epub 2007 Mar 1.
PMID: 17333294
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responsible party type: Principal Investigator
investigator affiliation: University of Erlangen-Nürnberg Medical School
investigator full name: Ali Behzad
investigator title: Dr. med.
mesh term: Hematologic Neoplasms
mesh term: Graft vs Host Disease
mesh term: Depression