se of home parenteral nutritional therapy in malnourished cancer patients: non-interventional study on efficacy and safety of therapy

Recruiting

• Conditions: R64; Cachexia

• Registration Number: DRKS00014686
• Lead Sponsor: otomed Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 254

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

Exclusion Criteria

Failure to meet the inclusion criteria

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is to assess the efficiency of home parenteral nutrition.<br>in malnourished tumor patients in the medical routine.<br>The primary parameter for determining the efficiency of therapy is the development of the<br>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 Outcome Measures

Name	Time	Method
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.