Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients (SpPN-HNC)
April 9, 2018 updated by: Jens Rikardt Andersen, University of Copenhagen
Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients - A Randomized Trial
The purpose of the study is to examine whether postoperative nutrition with endeavours of 100% coverage of the patient's estimated energy and protein needs, can reduce the incidence of postoperative complications.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark, 2100 Cph OE
- Clinic for Ear, Nose and Throat Surgery, Rigshospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who completed head and neck cancer surgery and got a feeding tube perioperatively
- Patients of legal age
- Patients who can understand and read Scandinavian languages
Exclusion Criteria:
- Patients with allergy to components in parenteral nutrition
- Patients where it is impossible to give parenteral nutrition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Intervention group
Supplementary parenteral nutrition
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Supplementary parenteral nutrition to achieve 100% coverage of estimated needs
|
|
No Intervention: Control group
The control group will receive standard nutritional care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Infectious Complications
Time Frame: At day 30
|
Local and systemic
|
At day 30
|
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Postoperative Thrombotic Complications
Time Frame: At day 30
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At day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fistula formation without infection defined by journal documentation
Time Frame: Day 1,2,3,4,7,14, 23 and 30
|
The measurement that will be used is documented fistula formation in the patients´ journal without increased infection parameters (c-reactive protein and leukocytes)
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Day 1,2,3,4,7,14, 23 and 30
|
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Number of participants who develop Refeeding Syndrome defined as a decrease in p-phosphate and clinical symptoms of refeeding syndrome; edema, dyspnea, hypertension, arrhythmia, confusion and/ or cases of spasm.
Time Frame: Day 2,3,4
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Data are collected from the patient's record.
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Day 2,3,4
|
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Number of participants who develop Refeeding Phenomena defined as a decrease in p-phosphate without clinical symptoms of refeeding syndrome; edema, dyspnea, hypertension, arrhythmia, confusion and/ or cases of spasm.
Time Frame: Day 2,3,4
|
Data will be collected from the patient's record.
|
Day 2,3,4
|
|
Length of stay at the hospital
Time Frame: Up to 30 days
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Up to 30 days
|
|
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Coverage of energy requirement, estimated by the Harris Benedict formula. Coverage is estimated by daily dietary registration.
Time Frame: Day 1,2,3,4
|
Day 1,2,3,4
|
|
|
Coverage of protein requirement, estimated in g/kg/day. The coverage is estimated by daily dietary registration.
Time Frame: Day 1,2,3, 4
|
Day 1,2,3, 4
|
|
|
Hand Grip Strength measured by a hand grip strength dynamometer in kilograms.
Time Frame: Baseline and Day 2,3,4
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Baseline and Day 2,3,4
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Biochemical Changes in Liver Parameters; p-alanine aminotransferase, p-bilirubin, alkaline phosphatase and INR (international normalized ratio).
Time Frame: Baseline and Day 2,3,4
|
Baseline and Day 2,3,4
|
|
Number of patients who develop coagulopathy defined as increase in INR (international normalized ratio) above the reference level.
Time Frame: Baseline and Day 2,3,4
|
Baseline and Day 2,3,4
|
|
Presence of nausea under treatment measured by a VAS-scale (visual analogue scale).
Time Frame: Day 2,3,4
|
Day 2,3,4
|
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Presence of oedema measured by weight in kg.
Time Frame: Day 2,3,4
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Day 2,3,4
|
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Causes of insufficient dietary intake, measured by a questionnaire filled out by the patient.
Time Frame: Day 2,3,4
|
Day 2,3,4
|
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Presence of vomiting under treatment registered by patient reported cases.
Time Frame: Day 2,3,4
|
Day 2,3,4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 18, 2016
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
December 8, 2016
First Submitted That Met QC Criteria
February 1, 2017
First Posted (Estimate)
February 3, 2017
Study Record Updates
Last Update Posted (Actual)
April 10, 2018
Last Update Submitted That Met QC Criteria
April 9, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-16042979
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.