NeoplasmsPATNICNCT04456647
Parenteral Nutrition Therapy in Patients With Incurable Cancer
An observational study of Neoplasms and Terminal Illness, run by Norwegian University of Science and Technology at 4 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Terminal Illness
- What is being tested?
- Parenteral nutrition
- How many people
- 507 participants
- Where
- 4 sitesNorway
- Study dates
- 1 Nov 2018to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patient with incurable cancer
- Use of parental nutrition in palliative setting
Who cannot join
- Still alive
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
Haukeland University Hospital
Bergen
Sykehuset Telemark
Skien
Sykehuset i Vestfold
Tønsberg
St Olavs Hospital
Trondheim
About this study
Official title: Parenteral Nutrition Therapy in Patients With Incurable Cancer - A Retrospective Analysis of Current Practice
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
- Being tested
- Parenteral nutrition
- Keywords
- Parenteral nutrition, Medical Records, Palliative Care, Disease Progression
- Medical subject headings
- Neoplasms, Hyperphagia, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenteral nutritionOther
Parenteral nutrition treatment in palliative care
| Study group | Role | What they receive |
|---|---|---|
| Parenteral nutrition | Not described Receives: Other: Parenteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Received dose of parenteral nutrition
Dose is measured in kcal/kg/day
Measured: From start of parenteral nutrition treatment to termination of parenteral nutrition, up to 3 years
Duration of treatment
Duration is measured in days
Measured: From start of parenteral nutrition treatment to termination of parenteral nutrition, up to 3 years
Survival
Survival is measured in days
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Nov 2018
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Sykehuset i Vestfold HF, Sykehuset Telemark, Haukeland University Hospital, University of Bergen, Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Trude Rakel Balstad, phd, Principal investigator, Norwegian University of Science and TechnologyTorstein Baade Rø, md phd, Study director, Norwegian University of Science and Technology, IKOMArne Solberg, md phd, Study director, Cancer Clinic, St. Olavs hospital, Trondheim University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456647
- Sponsor's protocol ID
- 2018/1500
- Acronym
- PATNIC
- Status last verified
- Aug 2023
- First submitted
- 8 Jun 2020
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenteral Nutrition Therapy in Patients With Incurable Cancer - A Retrospective Analysis of Current Practice
- ClinicalTrials.gov ID
- NCT04456647
- Acronym / sponsor ID
- PATNIC / 2018/1500
- Conditions
- Neoplasms, Terminal Illness
- Keywords
- Parenteral nutrition, Medical Records, Palliative Care, Disease Progression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 507 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Sykehuset i Vestfold HF, Sykehuset Telemark, Haukeland University Hospital, University of Bergen, Oslo University Hospital
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parenteral nutrition | – | Other: Parenteral nutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patient with incurable cancer
- Use of parental nutrition in palliative setting
Key exclusion criteria (1 listed)
- Still alive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenteral nutritionParenteral nutrition treatment in palliative care | Other | Parenteral nutrition |
Primary outcome
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
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
Survival
Time frame: From start of parenteral nutrition treatment to date of death, up to 7 years
Survival is measured in days
Indication for use of parenteral nutrition
Time frame: Baseline
Registered indication for use of parenteral nutrition treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trude Rakel Balstad, phd principal investigator
Norwegian University of Science and Technology
Torstein Baade Rø, md phd study director
Norwegian University of Science and Technology, IKOM
Arne Solberg, md phd study director
Cancer Clinic, St. Olavs hospital, Trondheim University hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Terminal Illness, run by Norwegian University of Science and Technology at 4 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Received dose of parenteral nutrition (time frame: From start of parenteral nutrition treatment to termination of parenteral nutrition, up to 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.