Unintentional weight loss in cancer diseases R64 R63 E40-E46
Conditions
Interventions
Group 1: Early HPN: max. unintended weight loss 15 % in 6 months (> 2,5 % / month)
Sponsors
B. Braun Melsungen AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - age > 18 years - cancer with a solid tumor - indication for a HPN - oral or enteral nutrition not possible or insufficient - signed informed consent
Exclusion criteria
Exclusion criteria: informed consent declined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chronological sequence of the body weight after early (max. unintended weight loss of 15% in 6 months) or late (unintended weight loss > 15% in 6 monthes) initiation of HPN. The body weight will be documented for a maximum period of 6 months (24 Weeks) in aprox. 4 weeks intervals. | — |
Secondary
| Measure | Time frame |
|---|---|
| - safety parameters (AE; katheter komplications, disease related side effects) - further effectiveness parameters, like chronological sequence of bioimpedance parameters, performance indices (Karnofsky, EGOC), lab parameters, as far as collected on a regular basis | — |
Countries
Germany
Contacts
Public ContactNorbert Nagel
B. Braun Melsungen AG
Outcome results
None listed