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NCT Number: NCT04456647

Parenteral Nutrition Therapy in Patients With Incurable Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital, Bergen, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Still alive

Treatment and study plan

Parenteral nutrition

Other

Parenteral nutrition treatment in palliative care

Primary outcomes

  1. Received dose of parenteral nutrition

    Time frame: From start of parenteral nutrition treatment to termination of parenteral nutrition, up to 3 years

    Dose is measured in kcal/kg/day

  2. Duration of treatment

    Time frame: From start of parenteral nutrition treatment to termination of parenteral nutrition, up to 3 years

    Duration is measured in days

  3. Survival

    Time frame: From start of parenteral nutrition treatment to date of death, up to 7 years

    Survival is measured in days

  4. Indication for use of parenteral nutrition

    Time frame: Baseline

    Registered indication for use of parenteral nutrition treatment

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Haukeland University Hospital
  • Oslo University Hospital
  • St. Olavs Hospital
  • Sykehuset Telemark
  • Sykehuset i Vestfold HF
  • University of Bergen

Registry information

Official study title

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

Acronym: PATNIC

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jul 2, 2020
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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