A prospective, controlled, multicentre non-interventional study of parenteral nutrition within the oncological outpatient care

A prospective, controlled, multicentre non-interventional study of parenteral nutrition within the oncological outpatient care - COM3CB

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00010078

Enrollment

200

Registered

2016-07-25

Start date

2016-10-14

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C00-C97

Interventions

Group 1: Patients who match the inclusion and exclusion criteria and who receive standardized parenteral nutrition (three-chamber bags) are observed in arm 1. Group 2: Patients who match the inclusio

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Total parenteral nutrition, outpatient care, ICD-10-GM C00-C97: Malignant neoplasms

Exclusion criteria

Exclusion criteria: - Inpatient care during observation period - Remaining life expectancy < 70 days 10 respectively 10 weeks - Terminal phase - Mental and behavioural disorders (ICD-10-GM F00 – F99) - Noninfective enteritis and colitis (ICD-10 GM K50 - K52) - Short bowel syndrome (ICD-10-GM K91.2) - Human immunodeficiency virus [HIV] disease (ICD-10-GM B20 – B24) - Parenteral nutrition with standardised three-chamber bags not possible due to medical reasons - Parenteral nutrition with individually compounded bags not possible due to medical reasons - Parenteral nutrition at an earlier time - cognitive deficits or insufficient speech comprehension - Non-compliance - Participation in a nutritional medical intervention study - Missing written informed consent

Design outcomes

Primary

Measure	Time frame
Health Related Quality of Life is assessed by means of the questionnaires EORTC QLQ-C30 and German HPN-QOL®. The questionnaires are filled in at the beginning of the observation, app. 8 weeks later and again app. 12 weeks after beginning the observation, if the patient still receives a parenteral nutrition at this time.	—

Secondary

Measure	Time frame
The Nutritional Status as secondary outcome is represented by five secondary endpoints: - Malnutrition Universal Screening Tool (MUST) - Body Weight - Body Mass Index - Albumin (as far as collected) - Bioelectrical Impedance Analysis (as far as carried out) The dates of documentation are the same as for HR-QoL: Baseline, after app. 8 weeks and, if the patient still receives parenteral nutrition, after app. 12 weeks.	—

Measure

Time frame

The Nutritional Status as secondary outcome is represented by five secondary endpoints: - Malnutrition Universal Screening Tool (MUST) - Body Weight - Body Mass Index - Albumin (as far as collected) - Bioelectrical Impedance Analysis (as far as carried out) The dates of documentation are the same as for HR-QoL: Baseline, after app. 8 weeks and, if the patient still receives parenteral nutrition, after app. 12 weeks.

—

Countries

Germany

Contacts

Public ContactJörn Kohnke

Onkologie Zentrum Süd

info@onkologiepraxis-remscheid.de02191 5 92 63 37

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026