Trial document




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  DRKS00014686

Trial Description

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Title

Use of home parenteral nutritional therapy in malnourished cancer patients: non-interventional study on efficacy and safety of therapy

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In this study, the treatment of malnourished cancer patients with artificial nutrition via infusion with industrially produced all-in-one mixtures and conventional injections (micronutrients, vitamins, trace elements, electrolytes) is observed in medical routine. In this case, the attending physician is not given any guidelines for the choice of therapy. It is investigated whether the therapy of these patients is improved by artificial nutrition.

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Brief Summary in Scientific Language

In this non-interventional study, the treatment of malnourished cancer patients with home parenteral nutrition with industrially produced all-in-one mixtures and usual injections (micronutrients, vitamins, trace elements, electrolytes) is observed in medical routine.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00014686
  •   2018/09/11
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  •   no
  •   Approved
  •   FF 42/2018, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

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Health Condition or Problem studied

  •   R64 -  Cachexia
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Interventions/Observational Groups

  •   Malnourished cancer patients under home parenteral nutrition therapy are regularly asked about their subjective perception of their quality of life over a period of up to 6 months using the WHO QOL BREF questionnaire. In parallel, further parameters such as blood values, SGA and manual force measurement are collected.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The primary objective of the study is to assess the efficiency of home parenteral nutrition.
in malnourished tumor patients in the medical routine.
The primary parameter for determining the efficiency of therapy is the development of the
Quality of life, assessed by comparing values to quality of life over time of a year, based on the baseline at the start of therapy.

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Secondary Outcome

The main secondary objectives of the study are the safety of therapy, determined by the frequency of port complications, the improvement of clinical parameters such as the stabilization of the weight or weight gain and stabilization of the Body Mass Index (BMI) or increase in BMI, the execution of chemotherapy without deviation in the case of standard dosages and therapy intervals measured by the dose intensity, the preservation or improvement of the patient's performance, the improvement of the general condition and the number of serious adverse events.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2019/01/22
  •   254
  •   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 confirmed tumor disease
- Indication for cytostatic drug therapy; planned, initiated or completed procedure
- Disease-related weight loss > 10% in the last six months before Inclusion in the NIS or Body mass index < 20. 0 kg/m2
- oral/enteral nutrition of < 500 kcal/kg/d for > 5 days or oral/entereral nutrition < 60% of the calculated requirement for > 10 days
- Subjective Global Assessment Grade C
- implanted central venous catheter (optional)
- Life expectancy at least three months

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Exclusion Criteria

Failure to meet the inclusion criteria

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Addresses

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    • otomed Pharma GmbH
    • Feringastrasse 9a
    • 85774  Unterföhring
    • Germany
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    • Medizinisches Versorgungszentrum Korbach gGmbH
    • Mr.  Kai  Tammoscheit 
    • Dr. Hartwig-Straße 19
    • 34497  Korbach
    • Germany
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    • Medizinisches Versorgungszentrum Korbach gGmbH
    • Mr.  Kai  Tammoscheit 
    • Dr. Hartwig-Straße 19
    • 34497  Korbach
    • Germany
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Sources of Monetary or Material Support

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    • otomed Pharma GmbH
    • Feringastr. 9A
    • 85774  Unterföhring
    • Germany
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Status

  •   Recruiting ongoing
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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.