Parenteral Nutrition Therapy in Patients With Incurable Cancer

Completed

• Conditions: Neoplasms; Terminal Illness
• Interventions: Other: Parenteral nutrition

• Registration Number: NCT04456647
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

Parenteral nutrition (PN) treatment in patients with incurable cancer is understudied and the level of evidence for clinical meaningful effects is weak. Guidelines give few specific recommendations regarding which patients with incurable cancer that should be offered PN treatment. According to the Norwegian prescription database, the use of parenteral nutrition has more than doubled in the period 2004-2015. These numbers do not separate between diagnoses and medical conditions, so the current use of medical nutrition in cancer patients in Norway is not known. The decision to initiate parenteral nutrition is taken at hospitals, whereupon the patient returns home to their respective municipalities and receives follow-up by the home care service. There are often uncertainties about the duration of treatment, as patients' clinical condition can change rapidly. One major challenge health care professionals face is to decide when to end medical nutrition therapy. Patients and relatives may experience fear that discontinuation of medical nutrition accelerates death, while health care professionals often experience that nutrition in many cases does not help and inflicts negatively on patients' condition. This makes communication concerning end of nutritional treatment between health care professionals at several health care levels, patients and their relatives challenging.

There is a need for a stronger evidence base considering the effect of medical nutrition in patients with incurable cancer. To be able to study the effect of PN treatment, more studies on clinical practice of PN treatment to patients with incurable cancer is needed. Aspects like indication for use, dosage and duration of PN treatment is poorly described in the available literature. Thus, the aim of this study is to describe indications for use of PN, duration of treatment, reasons for discontinuation, method of administration, possible benefits and complications as well as survival.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-29
• Study First Posted: 2020-07-02
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-14
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 507

Inclusion Criteria

• Patient with incurable cancer
• Use of parental nutrition in palliative setting

Exclusion Criteria

• Still alive

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parenteral nutrition	Parenteral nutrition	-

Primary Outcome Measures

Name	Time	Method
Received dose of parenteral nutrition	From start of parenteral nutrition treatment to termination of parenteral nutrition, up to 3 years	Dose is measured in kcal/kg/day
Indication for use of parenteral nutrition	Baseline	Registered indication for use of parenteral nutrition treatment
Survival	From start of parenteral nutrition treatment to date of death, up to 7 years	Survival is measured in days
Duration of treatment	From start of parenteral nutrition treatment to termination of parenteral nutrition, up to 3 years	Duration is measured in days

Trial Locations

Locations (4)

Haukeland University Hospital; 🇳🇴 Bergen, Norway

St Olavs Hospital; 🇳🇴 Trondheim, Norway

Sykehuset i Vestfold; 🇳🇴 Tønsberg, Norway

Sykehuset Telemark; 🇳🇴 Skien, Norway