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Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients (SpPN-HNC)

Primary Purpose

Head and Neck Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Parenteral Nutrition
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Neoplasm focused on measuring Supplementary Parenteral Nutrition, Postoperative Nutrition, Postoperative complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinic for Ear, Nose and Throat Surgery, Rigshospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Supplementary parenteral nutrition

The control group will receive standard nutritional care

Outcomes

Primary Outcome Measures

Postoperative Infectious Complications
Local and systemic
Postoperative Thrombotic Complications

Secondary Outcome Measures

Fistula formation without infection defined by journal documentation
The measurement that will be used is documented fistula formation in the patients´ journal without increased infection parameters (c-reactive protein and leukocytes)
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.
Data are collected from the patient's record.
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.
Data will be collected from the patient's record.
Length of stay at the hospital
Coverage of energy requirement, estimated by the Harris Benedict formula. Coverage is estimated by daily dietary registration.
Coverage of protein requirement, estimated in g/kg/day. The coverage is estimated by daily dietary registration.
Hand Grip Strength measured by a hand grip strength dynamometer in kilograms.

Full Information

First Posted
December 8, 2016
Last Updated
April 9, 2018
Sponsor
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT03042195
Brief Title
Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients
Acronym
SpPN-HNC
Official Title
Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients - A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 18, 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasm
Keywords
Supplementary Parenteral Nutrition, Postoperative Nutrition, Postoperative complications

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
Supplementary parenteral nutrition
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will receive standard nutritional care
Intervention Type
Other
Intervention Name(s)
Parenteral Nutrition
Intervention Description
Supplementary parenteral nutrition to achieve 100% coverage of estimated needs
Primary Outcome Measure Information:
Title
Postoperative Infectious Complications
Description
Local and systemic
Time Frame
At day 30
Title
Postoperative Thrombotic Complications
Time Frame
At day 30
Secondary Outcome Measure Information:
Title
Fistula formation without infection defined by journal documentation
Description
The measurement that will be used is documented fistula formation in the patients´ journal without increased infection parameters (c-reactive protein and leukocytes)
Time Frame
Day 1,2,3,4,7,14, 23 and 30
Title
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.
Description
Data are collected from the patient's record.
Time Frame
Day 2,3,4
Title
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.
Description
Data will be collected from the patient's record.
Time Frame
Day 2,3,4
Title
Length of stay at the hospital
Time Frame
Up to 30 days
Title
Coverage of energy requirement, estimated by the Harris Benedict formula. Coverage is estimated by daily dietary registration.
Time Frame
Day 1,2,3,4
Title
Coverage of protein requirement, estimated in g/kg/day. The coverage is estimated by daily dietary registration.
Time Frame
Day 1,2,3, 4
Title
Hand Grip Strength measured by a hand grip strength dynamometer in kilograms.
Time Frame
Baseline and Day 2,3,4
Other Pre-specified Outcome Measures:
Title
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
Title
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
Title
Presence of nausea under treatment measured by a VAS-scale (visual analogue scale).
Time Frame
Day 2,3,4
Title
Presence of oedema measured by weight in kg.
Time Frame
Day 2,3,4
Title
Causes of insufficient dietary intake, measured by a questionnaire filled out by the patient.
Time Frame
Day 2,3,4
Title
Presence of vomiting under treatment registered by patient reported cases.
Time Frame
Day 2,3,4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Clinic for Ear, Nose and Throat Surgery, Rigshospital
City
Copenhagen
ZIP/Postal Code
2100 Cph OE
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients

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