R64
Conditions
Interventions
Group 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 W
Sponsors
otomed Pharma GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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 5 days or oral/entereral nutrition 10 days - Subjective Global Assessment Grade C - implanted central venous catheter (optional) - Life expectancy at least three months
Exclusion criteria
Exclusion criteria: Failure to meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactKai Tammoscheit
Medizinisches Versorgungszentrum Korbach gGmbH
Outcome results
None listed