Trial document




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  DRKS00007954

Trial Description

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Title

Prospective non-interventional double trial regarding tumor-about fatigue syndrome during taxane therapy - Version FaTa-D(ocetaxel)

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Trial Acronym

FaTa-D

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URL of the Trial

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Brief Summary in Lay Language

The objective of this by LIV Pharma GmbH sponored study according to § 67 para. 6 AMG is the collection of data that allows the scientific answer to study questions listed below. In addition data on the efficay and safety of docetaxel LIV Pharma in the routine treatment of different tumors should be obtained.
In a non-interventional observational study (NIS) was no instructions or recommendation are given for diagnosis, treatment and follow-up examinations during the course of the therapy. The objective is documentation of therapy data only against the background of specific oncologic therapy and in the context of the defined questions of interest.
The participation of a study physician has not influence on his/her therapy decisions or diagnostic measures during the course of the study and thereafter.
The study was registered at the KBV, GKV, PKV and BfArM (BfArM number 2071).
Participating investigators are reported periodically to these institutions and authorities.
According to law it is prohibited to use drug samples for a non-interventional study (NIS).
The study objectives, terms of participation and means for documentation and analysis of this non-interventional study were submitted to the Lead Physician’s ethics committee of this study. The EC consultation led to a positive judgment in terms of professional law and ethics.

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Brief Summary in Scientific Language

The following questions should be answered in the context of this prospective epidemiological study regarding taxane therapy with docetaxel LIV Pharma:

- Do dose regimen and dosing intervals have influence on the occurrence of tumor-associated fatigue?
- Do the combination partners influence fatigue syndrome when docetaxel is used?
- Have existing mental illnesses or treatments influence on the occurrence of fatigue syndrome?
- What impact have other psychosocial stress factors on the treatment outcome and the occurrence of Fatigue Syndrome?
- Doo regular exercise or physical activity have positive impact on the fatigue problem?
- Is the reported incidence and type of other side effects depending on the occurrence a fatigue syndrome?
- Will this study contribute to relevant health economic aspects?

This study is designed as part of a double trial. The identical questions are also investigated in trial with Paclitaxel LIV Pharma. The objetive is to compare the data of both studies later at a later stage.


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Organizational Data

  •   DRKS00007954
  •   2015/03/30
  •   [---]*
  •   no
  •   Approved
  •   EK-BR-102/14-1, Ethikkommission bei der Sächsischen Landesärztekammer
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Secondary IDs

  •   U1111-1168-8270 
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Health Condition or Problem studied

  •   Fatigue, Tumor associated
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Interventions/Observational Groups

  •   Patients with histologically or cytologically diagnosted various tumor entities for which a treatment with docetaxel LIV pharmaceutical according to SPC is indicated.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Course of Fatigues yndroms, collected using questionnaire MFI (multidimensional fatigue inventory) at baseline, 2,4,6,8,12 cycles, end of treatment and 1 follow-up visits end of treatment and follow-up examinations 1-3

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Secondary Outcome

Course of the quality of life collected by questionnaire EORTC-C30 v 3.0 at baseline, cycle 4, 8, 12, end of treatment and follow-up examinations 1-3

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2015/04/01
  •   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

- Histologically or cytologically diagnosted Tumors for which docetaxel LIV Pharma is approved according to SPC.
- Age: over 18 years
- Docetaxel LIV Pharma is used in therapy.
- A hand signed and dated informed consent is available.

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Exclusion Criteria

- Contraindications regarding the use of docetaxel LIV pharmaceutical according to expert information
- The current therapy was started more than 12 weeks ago.
- The patient is participating simultaneously part in another 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 14;
    • D-82041  Oberhaching
    • Germany
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    • Datafaber GbR
    • Mr.  Dr  Burkard  Heckelbacher 
    • Kantstrasse 15
    • 85356  Freising
    • Germany
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    • Onkozentrum Dresden
    • Mr.  Dr.  Thomas  Göhler 
    • Leipziger Str. 118-120
    • 01127  Dresden
    • Germany
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    • Onkozentrum Dresden
    • Mr.  Dr.  Thomas  Göhler 
    • Leipziger Str. 118-120
    • 01127  Dresden
    • Germany
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Sources of Monetary or Material Support

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    • LIV Pharma GmbH
    • Mr.  Lars  Schöttler 
    • Bajuwarenring 14;
    • D 82041  Oberhaching
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   2017/10/11
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Trial Publications, Results and other Documents

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