Trial document




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  DRKS00010688

Trial Description

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Title

The influence of individual parenteral nutrition in oncology – two-year Non-Interventional study in patients suffering from oncological disease and with individual parenteral nutrition (STIPEO)

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Trial Acronym

NIS STIPEO

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URL of the Trial

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Brief Summary in Lay Language

Within the scope of non-interventional study STIPEO should be investigated how would be changed the nutritional condition under therapy with individual compounded parenteral (through direct administration into the blood stream) food. It also should be investigated effects of this individual nutrition therapy on quality of life for patients suffering from oncological disease and whether it is possible to draw conclusions concerning an early date of start of parenteral nutrition in malnourished patients.
The main objective of the nutrition therapy is the prevention or treatment of malnutrition. Other objectives include a better response to the anti-tumor therapy with fewer side effects and an improved quality of life with lower infection rates, shorter hospitalizations and a reduction in costs. By tumor-associated malfunctions of the gastrointestinal tract (digestive tract), metabolic and functional changes, as well as side effects of treatment such as mucositis (inflammation of the stomach lining), vomiting or diarrhea, oral or enteral (via intestines) nutrition therapy is no longer sufficient. The indication for parenteral nutrition to meet the energy and nutrient requirements is when a patient can eat neither orally nor enterally, there is a fasting of more than seven days or malnutrition.
Through the use of compounded nutrient solution the composition is individually tailored to the patient's needs.
The data collection and documentation are carried out by treating physician / health care professional via paper-CRF. The complete documentation of treatment data of a patient contains 4 observation points. The individual observation period of a patient is 6 months.

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Brief Summary in Scientific Language

Rationale: observation of the benefits of an individual parenteral nutrition in patients during or after chemotherapy regarding weight gain, nutritional condition and quality of life.
Indication: Patients with an oncological disease during or after chemotherapy and existing indication for an individual parenteral nutrition
Patient Population: hemato-oncologic, gynaecologic-oncologic and urological-oncologic patients with individual parenteral nutrition and treated with chemotherapy or patients who receive no chemotherapy
Treatment: individual parenteral nutrition in accordance with § 7 Apothekenvertriebsordnung (ApBetrO)
The benefits of an individual parenteral nutrition in patients during or after chemotherapy regarding weight gain and nutritional condition should be observed. For the assessment of nutrition it will be used the MUST-scale. Even the quality of life should be observed. This is carried out on the basis of FACT-G-questionnaire (version 4, German).
A secondary objective of the study is to examine the safety profile of individual parenteral nutrition. It is done by detecting (serious) adverse events and (serious) adverse events with suspected relationship for parenteral nutrition in accordance with Common Toxicity Criteria for Adverse Events (CTCAE, v.4.03). Also to be analysed the indication of individual parenteral nutrition on the basis of Subjective Global Assessments (SGA). And the conformity of the indication for individual parenteral nutrition should be checked with the guidelines of DGEM (the German Academy for Nutritional Medicine).
The data collection and documentation are carried out by treating physician / health care professional via paper-CRF. The complete documentation of treatment data of a patient contains 4 observation points. The individual observation period of a patient is 6 months.
Statistical aspects: The evaluation of collected parameters will be analysed with descriptive statistics.
The severity level, absolute and relative frequencies of all adverse events will be represented.

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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

  •   DRKS00010688
  •   2016/07/05
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  •   no
  •   Approved
  •   Eth-19/16, Ethik-Kommission der Ärztekammer Berlin
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Secondary IDs

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Health Condition or Problem studied

  •   C00-C97 -  Malignant neoplasms
  •   E40-E46 -  Malnutrition
  •   K93.8 -  Disorders of other specified digestive organs in diseases classified elsewhere
  •   individual parenteral nutrition
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Interventions/Observational Groups

  •   Within the scope of non-interventional study STIPEO should be investigated how would be changed the nutritional condition under therapy with individual compounded parenteral (through direct administration into the blood stream) food. It also should be investigated effects of this individual nutrition therapy on quality of life for patients suffering from oncological disease and whether it is possible to draw conclusions concerning an early date of start of parenteral nutrition in malnourished patients.

    The complete documentation of treatment data of a patient contains 4 observation points. The individual observation period of a patient is 6 months.
    For the assessment of nutrition it will be used the MUST-scale (MUST=Malnutrition Universal Screening Tool).
    Data about the quality of life will be collected by using FACT-G-questionnaire (FACT-G=Functional Assessment of Cancer Therapy-General).

    observation points:
    At the start of the individual parenteral nutrition the patients with oncological diseases will be first documented on organ, stage. Also data about therapy, therapy line, body weigth will be collected. The analysis using the MUST-scale and FACT-G will be carried out at baseline. After 28 days, at visit 1, data will be collected using FACT-G questionnaire. At visit 2, 56 days after the start of individual parental nutrition, the patient status should be recorded. The final documentation will take place after 6 month from start of individual parenteral nutrition or with death. Thereby the detection is carried out by FACT- G .
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Characteristics

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

- Observation of the benefits of an individual parenteral nutrition in patients during or after chemotherapy regarding weight gain and nutritional condition. For the assessment of nutrition it will be used the MUST-scale.
- Observation of the quality of life of patients with individual parenteral nutrition and treated with chemotherapy or patients who receive no chemotherapy. This is carried out on the basis of FACT-G-questionnaire (version 4, german).

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Secondary Outcome

- the safety profile of individual parenteral nutrition
It is done by detecting (serious) adverse events and (serious) adverse events with suspected relationship for parenteral nutrition in accordance with Common Toxicity Criteria for Adverse Events (CTCAE, v.4.03).
- analysis of the indication of individual parenteral nutrition on the basis of Subjective Global Assessments (SGA)
- the conformity of the indication for individual parenteral nutrition with the guidelines of DGEM (the German Academy for Nutritional Medicine)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2016/12/22
  •   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

- signed patient consent form
- age ≥ 18 years
- oncological disease
- indication for individual parenteral nutrition

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Exclusion Criteria

- known hypersensitivity against agents and excipients or other ingredients of a parenteral nutrition

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Addresses

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    • ALPHAMADE GmbH
    • Döbelner Straße 5
    • 12627  Berlin
    • Germany
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    • ONKODATAMED
    • Ms.  Anna  Merk 
    • Friedenstraße 58
    • 15366  Neuenhagen bei Berlin
    • Germany
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    • ONKODATAMED
    • Anna  Merk 
    • Friedenstraße 58
    • 15366  Neunhagen bei Berlin
    • Germany
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Sources of Monetary or Material Support

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    • ALPHAMADE GmbH
    • Döbelner Straße 5
    • 12627  Berlin
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   2018/05/18
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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.