Parenteral Nutrition Therapy in Patients With Incurable Cancer

NCT04456647 | Completed

• 1 other identifier: 2018/1500
• Study Type: observational
• Target: 507
• Locations: 1 country
• Sites: 4

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

Keywords

Parenteral nutrition; Medical Records; Palliative Care; Disease Progression

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Parenteral nutrition

Other: Parenteral nutrition

Interventions

Parenteral nutrition OTHER

Parenteral nutrition treatment in palliative care

Parenteral nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Still alive

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• Sykehuset i Vestfold HF: collaborator
• Sykehuset Telemark: collaborator
• Haukeland University Hospital: collaborator
• University of Bergen: collaborator
• Oslo University Hospital: collaborator

Study Sites (4)

Haukeland University Hospital

Bergen, Norway

Location

Sykehuset Telemark

Skien, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Sykehuset i Vestfold

Tønsberg, Norway

Location

MeSH Terms

Conditions

Neoplasms; Hyperphagia; Disease Progression

Interventions

Parenteral Nutrition

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Trude Rakel Balstad, phd

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Torstein Baade Rø, md phd

  Norwegian University of Science and Technology, IKOM

  STUDY DIRECTOR

• Arne Solberg, md phd

  Cancer Clinic, St. Olavs hospital, Trondheim University hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: July 2, 2020
• Study Start: November 1, 2018
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (4)