Parenteral Nutrition Therapy in Patients With Incurable Cancer

Neoplasms Clinical Trial

— PATNIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04456647
• Other study ID #: 2018/1500
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: May 1, 2023

Study information

• Verified date: August 2023
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 507
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with incurable cancer

• Use of parental nutrition in palliative setting

Exclusion Criteria:

• Still alive

Related Conditions & MeSH terms

• Neoplasms
• Terminal Illness

Intervention

Other:
• Parenteral nutrition
Parenteral nutrition treatment in palliative care

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Sykehuset Telemark	Skien
Norway	Sykehuset i Vestfold	Tønsberg
Norway	St Olavs Hospital	Trondheim

Sponsors (7)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Haukeland University Hospital, Oslo University Hospital, St. Olavs Hospital, Sykehuset i Vestfold HF, Sykehuset Telemark, University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Duration of treatment	Duration is measured in days	From start of parenteral nutrition treatment to termination of parenteral nutrition, up to 3 years
Primary	Survival	Survival is measured in days	From start of parenteral nutrition treatment to date of death, up to 7 years
Primary	Indication for use of parenteral nutrition	Registered indication for use of parenteral nutrition treatment	Baseline