Clinical trial NCT04456647: Parenteral Nutrition Therapy in Patients With Incurable Cancer
Official title: Parenteral Nutrition Therapy in Patients With Incurable Cancer - A Retrospective Analysis of Current Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Terminal Illness
Keywords: Parenteral nutrition
Medical Records
Palliative Care
Disease Progression
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Sykehuset i Vestfold HF
name: Sykehuset Telemark
name: Haukeland University Hospital
name: University of Bergen
name: Oslo University Hospital
First posted: 2020-07-02
Enrollment: 507
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective medical record review includes adult patients with incurable cancer who received parenteral nutrition treatment in palliative care in the time period, January 2011 to December 2017. Only patients who were deceased at point of data abstraction are included.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Still alive

Primary outcomes:
measure: Received dose of parenteral nutrition
timeFrame: From start of parenteral nutrition treatment to termination of parenteral nutrition, up to 3 years
measure: Duration of treatment
timeFrame: From start of parenteral nutrition treatment to termination of parenteral nutrition, up to 3 years
measure: Survival
timeFrame: From start of parenteral nutrition treatment to date of death, up to 7 years
measure: Indication for use of parenteral nutrition
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Skien
country: Norway
facility: Sykehuset Telemark
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Tønsberg
country: Norway
facility: Sykehuset i Vestfold
Study officials:
affiliation: Norwegian University of Science and Technology
name: Trude Rakel Balstad, phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian University of Science and Technology, IKOM
name: Torstein Baade Rø, md phd
role: STUDY_DIRECTOR
affiliation: Cancer Clinic, St. Olavs hospital, Trondheim University hospital
name: Arne Solberg, md phd
role: STUDY_DIRECTOR
References: