Trial document

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DRKS-ID: 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

DRKS-ID: DRKS00014686
Date of Registration in DRKS: 2018/09/11
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): no
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: FF 42/2018, Ethikkommission der Landesärztekammer Hessen

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Secondary IDs

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Health Condition or Problem studied

ICD10: R64 - Cachexia

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Interventions/Observational Groups

Arm 1: 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

Study Type: Non-interventional
Study Type Non-Interventional: Epidemiological study
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Supportive care
Assignment: Single (group)
Phase: N/A
Off-label Drug use: 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

DE: Germany

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Locations of Recruitment

other MVZ, Korbach
Doctor's Practice Hessen
Doctor's Practice Niedersachsen
Doctor's Practice Nordrhein-Westfalen

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2019/01/22
Target Sample Size: 254
Monocenter/Multicenter trial: Multicenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 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

Primary Sponsor
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- otomed Pharma GmbH
- Feringastrasse 9a
- 85774 Unterföhring
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.otomed.de
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Contact for Scientific Queries
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- Medizinisches Versorgungszentrum Korbach gGmbH
- Mr. Kai Tammoscheit
- Dr. Hartwig-Straße 19
- 34497 Korbach
- Germany
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- Telephone: 05631 569 703
- Fax: [---]*
- E-mail: cro at otocare.de
- URL: [---]*
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Contact for Public Queries
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- Medizinisches Versorgungszentrum Korbach gGmbH
- Mr. Kai Tammoscheit
- Dr. Hartwig-Straße 19
- 34497 Korbach
- Germany
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- Telephone: 089 414142666
- Fax: [---]*
- E-mail: studie01hpe18 at otocare.de
- URL: [---]*
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Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)
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- otomed Pharma GmbH
- Feringastr. 9A
- 85774 Unterföhring
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*

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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.