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)
- Conditions
- individual parenteral nutritionC00-C97E40-E46K93.8Malignant neoplasmsMalnutritionDisorders of other specified digestive organs in diseases classified elsewhere
- Registration Number
- DRKS00010688
- Lead Sponsor
- ALPHAMADE GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 3
Inclusion Criteria
signed patient consent form
- age = 18 years
- oncological disease
- indication for individual parenteral nutrition
Exclusion Criteria
- known hypersensitivity against agents and excipients or other ingredients of a parenteral nutrition
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - 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.<br>- 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). <br>
- Secondary Outcome Measures
Name Time Method - the safety profile of individual parenteral nutrition<br>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).<br>- analysis of the indication of individual parenteral nutrition on the basis of Subjective Global Assessments (SGA)<br>- the conformity of the indication for individual parenteral nutrition with the guidelines of DGEM (the German Academy for Nutritional Medicine)