Parenteral Nutrition Therapy in Patients With Incurable Cancer

NCT ID: NCT04456647

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 507 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2023-05-01

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.

Conditions

Neoplasms; Terminal Illness

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Parenteral nutrition

Parenteral nutrition

Intervention Type: OTHER

Parenteral nutrition treatment in palliative care

Interventions

Parenteral nutrition

Parenteral nutrition treatment in palliative care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Still alive

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Sykehuset i Vestfold HF

OTHER

Sponsor Role: collaborator

Sykehuset Telemark

OTHER_GOV

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Trude Rakel Balstad, phd

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Torstein Baade Rø, md phd

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology, IKOM

Arne Solberg, md phd

Role: STUDY_DIRECTOR

Cancer Clinic, St. Olavs hospital, Trondheim University hospital

Locations

Haukeland University Hospital

Bergen, , Norway

Sykehuset Telemark

Skien, , Norway

St Olavs Hospital

Trondheim, , Norway

Sykehuset i Vestfold

Tønsberg, , Norway

Countries

Norway

Other Identifiers

2018/1500

Identifier Type: -

Identifier Source: org_study_id