Parenteral Nutrition Therapy in Patients With Incurable Cancer (PATNIC)

Parenteral Nutrition Therapy in Patients With Incurable Cancer - A Retrospective Analysis of Current Practice

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Terminal Illness
• Intervention / Treatment: Other: Parenteral nutrition

• Study Type: Observational
• Enrollment (Actual): 507

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway
    • Haukeland University Hospital
  • Skien, Norway
    • Sykehuset Telemark
  • Trondheim, Norway
    • St Olavs Hospital
  • Tønsberg, Norway
    • Sykehuset i Vestfold

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Still alive

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Parenteral nutrition	Other: Parenteral nutrition; Parenteral nutrition treatment in palliative care

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Oslo University Hospital; University of Bergen; Haukeland University Hospital; St. Olavs Hospital; Sykehuset Telemark; Sykehuset i Vestfold HF
• Investigators: Study Director: Torstein Baade Rø, md phd, Norwegian University of Science and Technology, IKOM; Principal Investigator: Trude Rakel Balstad, phd, Norwegian University of Science and Technology; Study Director: Arne Solberg, md phd, Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Palliative Care; Disease Progression; Parenteral nutrition; Medical Records
• Other Study ID Numbers: 2018/1500

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No