Trial document





This trial has been registered retrospectively.
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  DRKS00017083

Trial Description

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Title

Observational study for the efficacy of add-on non-pharmaceutical interventions and of Viscum album extract for the treatment of patients with lung carcinoma

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Trial Acronym

ACCEPT-2 Anthroposophic medicine therapy concept of early or palliative care in lung cancer treatment

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URL of the Trial

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Brief Summary in Lay Language

Lung carcinoma is one of the most malignant diseases with a high mortality. 75% of the patients are diagnosed at an advanced stage with an average survival of 12 months and high symptomatic burden. Due to impaired quality of life (QOL) and poor prognosis non-pharmaceutical interventions (NPI) are of special importance and for the improvement of QOL and are recommended by guidelines. Temel et al. indicated efficacy of early NPI for the first time. Further studies on add-on NPIs for the treatment of newly diagnosed lung carcinoma were published. Until now no specific NPI program has been validated. In the lung cancer center Havelhöhe certified by the German Cancer Association (DKG) a multimodal treatment program (ACCEPT-protocol, AP) has been developed during the last years. The efficacy of APwill be examined during the present study with three parallel patient groups.

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Brief Summary in Scientific Language

Lung carcinoma is one of the most malignant diseases with a high mortality. 75% of the patients are diagnosed at an advanced stage with an average survival of 12 months and high symptomatic burden. Due to impaired quality of life (QOL) and poor prognosis non-pharmaceutical interventions (NPI) are of special importance and for the improvement of QOL and are recommended by guidelines. Temel et al. indicated efficacy of early NPI for the first time. Further studies on add-on NPIs for the treatment of newly diagnosed lung carcinoma were published. Until now no specific NPI program has been validated. In the lung cancer center Havelhöhe certified by the German Cancer Association (DKG) a multimodal treatment program (ACCEPT-protocol, AP) has been developed during the last years. The efficacy of APwill be examined during the present study with three parallel patient groups. A psychometric capture of QOL of the patients will be performed at various time points. In addition clinical data will be collected, the time until tumor progression (PFS) and overall survival time (OS).The therapy of lung carcinoma can be improved with regards to QOL (primary endpoint TOI), PFS and OS when patients undergo an early add-on NPI program. All therapy modules are part of the standard integrative oncology treatment at the lunc cancer center Havelhöhe.

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Organizational Data

  •   DRKS00017083
  •   2019/06/19
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  •   yes
  •   Approved
  •   EA1/231/16, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Patients receiving guideline-oriented therapy of lung carcinoma according to the advice of the tumor board (DKG standard). The add-on Viscum album therapy ist offered to the patients and is not dependent on special selection to a study arm. All modules are part of the standard integrative oncology treatment at the lunc cancer center Havelhöhe.
  •   Patients receiving additionally modul 1 (psychoeducation) or modul 2 (psychooncological conversation). The add-on Viscum album therapy ist offered to the patients and is not dependent on special selection to a study arm. All modules are part of the standard integrative oncology treatment at the lunc cancer center Havelhöhe.
  •   Patients receiving additionally modul 1 (psychoeducation), modul 2 (psychooncological conversation) and modul 3 (ARTs-therapy). For the ARTs-therapy the following modalities can be chosen: a) breathing-movement, b) breathing-speech, c) breathing-singing. The add-on Viscum album therapy ist offered to the patients and is not dependent on special selection to a study arm. All modules are part of the standard integrative oncology treatment at the lunc cancer center Havelhöhe.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
  •   Yes
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Primary Outcome

QoL (Quality of life): FACT-TOI questionnaire, at the time points 0, 3, 6 und 12 , 24 und 36 weeks

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Secondary Outcome

QoL (Quality of Life) with the questionnaires FACT-L, FACT-TOI, CFS-D, PSQI, HADS, IPQR, F-Sozu, FEAV, PAF, State aR, Grossarth-Maticek's self-regulation and distress barometer, in addition overall survival and progression free survival; time points 0, 3, 6 und 12 , 24 und 36 weeks

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/02/01
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

Written informed consent, patients with primary lung carcinoma (stage UICC IIA - IVB - 8th edition), knowledge of Geman language, can expected to undergo a 3-months program (ECOG 0-2), inclusion within 4 weeks of primary diagnosis, if necessary plus 3 months depending on therapy

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Exclusion Criteria

Primary lung carcinoma UICC I (8th edition), no written consent

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Addresses

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    • Forschungsinstitut Havelhöhe (FIH) gGmbH am Gemeinschaftskrankenhaus Havelhöhe
    • Kladower Damm 221
    • 14089  Berlin
    • Germany
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    • Forschungsinstitut Havelhöhe (FIH) gGmbH am Gemeinschaftskrankenhaus Havelhöhe
    • Mr.  Dr.  Christian  Grah 
    • Kladower Damm 221
    • 14089  Berlin
    • Germany
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    • Forschungsinstitut Havelhöhe (FIH) gGmbH am Gemeinschaftskrankenhaus Havelhöhe
    • Mr.  Dr.  Christian  Grah 
    • Kladower Damm 221
    • 14089  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Forschungsinstitut Havelhöhe (FIH) gGmbH am Gemeinschaftskrankenhaus Havelhöhe
    • Kladower Damm 221
    • 14089  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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