Trial document





This trial has been registered retrospectively.
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  DRKS00007953

Trial Description

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Title

Prospective non-interventional study of tumor-associated fatigue syndrome under Anthracyclintherapie - Face -E (pirubicin)

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Trial Acronym

FAce –E(pirubicin)

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URL of the Trial

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Brief Summary in Lay Language

The fatigue syndrome is a side effect in cancer patients, which is caused by the disease itself or in conjunction with chemotherapy or radiation. It lasts usually for weeks or even months after end of treatment period and also affects the quality of life considerably. Typical symptoms are persistent weakness and fatigue despite sufficient phases of sleep, the feeling of overload even at exposition to low stress and a significant decrease in terms of private and professional activities. These symptoms thus also have significant impact in terms of health econonomics.
Due to psychological and oncological care of cancer patients fatigue is no more and more in the focus of clinical research.
The objective of this NIS, which is sponsored by LIV Pharma GmbH in accordance with § 67 paragraph 6 AMG, is to collect data in order to answer the questions below in a scientific way. In addition data are collected regarding the efficiency and safety of epirubicin LIV Pharma in treatment against different tumor entities under routine practice conditions.
In a non-interventional observational study (NIS) no recommendations for conduct of diagnostics or therapy are made. The objective is documentation of treatment routine practice in light of the study question. Participation in this study does not affect the doctor’s independence regarding therapy and diagnostics, either during or after study participation.
The study was registered at the KBV, GKV, PKV and the BfArM (Federal Institute for Drugs and Medical Devices). Participating investigators are reported periodically to the authorities
The law does not allow the use of drug samples in non-interventional study (NIS).
The question and the terms and conditions of this non-interventional study were submitted to an ethics commission and positive opinion was obtained. The obligation of ethical and professional consultation of participating doctors was fulfilled.

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Brief Summary in Scientific Language

In order to observe tumor-Fatigue as objectively as possible, the MFI 20 Fatigue Scale questionnaire is used. This NIS is to quantify the incidence of the fatigue-syndrome in routine practice associated to Epirubicin free of any bias, based on a non-selective sample which is representative in terms of size. With regard to the usual pharmacological approaches and non-pharmakological rmeasures in routine practice a representative survey of therapeutic success will be generated. Thereby quality of life will be assessed. For subjective evaluation of the course of therapy by study patient the validated FACT (Functional Assessment of Cancer Therapy) will be used.
Apart from the pharmacological approaches usual in routine practice, also increase in activity is referred to as a non-pharmakological therapeutic approach. The BSA questionnaire will be used in this NIS in order to record and access the exercise and sports activity.
The evaluation of these NIS contribute to hypothesis generation of future controlled studies.
The following questions should be answered in the context of this prospective epidemiological study about anthracycline therapy with epirubicin LIV Pharma:
•Do dose regimen and dosing intervals influence the occurrence of tumor-associated fatigue?
•Due combination compounds influence the Fatigue Syndrome in the use of Epi-rubicin?
•Have existing mental illnesses / treatments influence on the occurrence of fatigue syndrome?
•What impact do other psychosocial stress have on the therapy success and extent of Fatigue Syndrome?
•Do regular sports / exercise improves fatigue problems?
•Is the reported frequency and kind of other side effects depending on the occurrence of fatigue syndrome?
•Are there side effects in the routine use of epirubicin LIV Pharma which were not reported yet?
•Are there relevant conclusions in terms of health economics based on the results of this study.

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Organizational Data

  •   DRKS00007953
  •   2015/08/25
  •   2015/08/18
  •   no
  •   Approved
  •   2015-001-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   U1111-1173-3763 
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Health Condition or Problem studied

  •   Fatigue, tumor asscociated
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Interventions/Observational Groups

  •   In this patients with histologically or cytologically various diagnosed tumor entities are observed where treatment with epirubicin LIV pharmaceutical according to the SPC is indicated.
    There are the special warnings and precautions for use in the SPC of epirubicin LIV to be addressed.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Efficacy and Tolerability routine practice. Observational, non-interventional study.

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Secondary Outcome

Side effects which were not observed so far.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2015/06/17
  •   500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• histological or cytological tumors of the breast or ovaries, where epirubicin LIV pharmaceuticals is indicated according to SPC
• Age: over 18 years
• Epirubicin LIV Pharma is used in therapy.
• A hand signed and dated informed consent is present.
• The therapy was chosen independently from possible enrollment

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Exclusion Criteria

• contraindications to the use of epirubicin LIV Pharma loud Fach¬information
• The current therapy was started more than 12 weeks ago.
• The patient is participatiing in a clinical trial
• A pregnancy is present or the patient is breastfeeding

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Addresses

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    • LIV Pharma GmbH
    • Mr.  Lars  Schöttler 
    • Bajuwarenring
    • 82041  Oberhaching
    • Germany
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    • Datafaber GbR
    • Mr.  Dr  Burkard  Heckelbacher 
    • Kantstrasse 15
    • 85356  Freising
    • Germany
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    • Marienhospital Bottrop
    • Mr.  Dr. med.  Hans-Christian  Kolberg 
    • Josef-Albers-Str. 70
    • 46236  Bottrop
    • Germany
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    • Marienhospital Bottrop
    • Mr.  Dr. med.  Hans-Christian  Kolberg 
    • Josef-Albers-Str. 70
    • 46236  Bottrop
    • Germany
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Sources of Monetary or Material Support

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    • LIV Pharma GmbH
    • Mr.  Lars  Schöttler 
    • Bajuwarenring
    • 82041  Oberhaching
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   2017/10/10
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.