PATNIC: Parenteral Nutrition Therapy in Patients With Incurable Cancer

• Sponsor: Norwegian University of Science and Technology (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04456647
• Collaborator: St. Olavs Hospital (Other), Sykehuset i Vestfold HF (Other), Sykehuset Telemark (Other), Haukeland University Hospital (Other), University of Bergen (Other), Oslo University Hospital (Other)
• Enrollment: 480
• Locations: 4
• Anticipated Duration (Months): 61.7
• Patients Per Site: 120
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

Parenteral nutrition (PN) treatment in patients with incurable cancer is understudied and the level of evidence for clinical meaningful effects is weak. The ESPEN 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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms; Terminal Illness	Other: Parenteral nutrition

Study Design

• Study Type: Observational
• Anticipated Enrollment: 480 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Parenteral Nutrition Therapy in Patients With Incurable Cancer - A Retrospective Analysis of Current Practice
• Actual Study Start Date: Nov 1, 2018
• Anticipated Primary Completion Date: Dec 23, 2023
• Anticipated Study Completion Date: Dec 23, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Received dose of parenteral nutrition [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 [From start of parenteral nutrition treatment to termination of parenteral nutrition, up to 3 years]

   Duration is measured in days

3. Survival [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 [Baseline]

   Registered indication for use of parenteral nutrition treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient with incurable cancer

• Use of parental nutrition in palliative setting

Exclusion Criteria:

• Still alive

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haukeland University Hospital	Bergen		Norway
2	Sykehuset Telemark	Skien		Norway
3	St Olavs Hospital	Trondheim		Norway
4	Sykehuset i Vestfold	Tønsberg		Norway

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Trude Rakel Balstad, phd, Norwegian University of Science and Technology
• Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT04456647
• Other Study ID Numbers: 2018/1500
• First Posted: Jul 2, 2020
• Last Update Posted: Apr 25, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Norwegian University of Science and Technology: Parenteral nutrition; Medical Records; Palliative Care; Disease Progression

Study Results

No Results Posted as of Apr 25, 2022