individual parenteral nutrition C00-C97 E40-E46 K93.8
Conditions
Interventions
Group 1: 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 a
Sponsors
ALPHAMADE GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - signed patient consent form - age = 18 years - oncological disease - indication for individual parenteral nutrition
Exclusion criteria
Exclusion criteria: - known hypersensitivity against agents and excipients or other ingredients of a parenteral nutrition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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) | — |
Countries
Germany
Contacts
Public ContactAnna Merk
ONKODATAMED
Outcome results
None listed