Clinical trial NCT03042195: Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients
Official title: Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients - A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Neoplasm
Keywords: Supplementary Parenteral Nutrition
Postoperative Nutrition
Postoperative complications
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Postoperative Infectious Complications
timeFrame: At day 30
measure: Postoperative Thrombotic Complications
timeFrame: At day 30
Secondary outcomes:
measure: Fistula formation without infection defined by journal documentation
timeFrame: Day 1,2,3,4,7,14, 23 and 30
measure: 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.
timeFrame: Day 2,3,4
measure: 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.
timeFrame: Day 2,3,4
measure: Length of stay at the hospital
timeFrame: Up to 30 days
measure: Coverage of energy requirement, estimated by the Harris Benedict formula. Coverage is estimated by daily dietary registration.
timeFrame: Day 1,2,3,4
measure: Coverage of protein requirement, estimated in g/kg/day. The coverage is estimated by daily dietary registration.
timeFrame: Day 1,2,3, 4
measure: Hand Grip Strength measured by a hand grip strength dynamometer in kilograms.
timeFrame: Baseline and Day 2,3,4
Other outcomes:
measure: Biochemical Changes in Liver Parameters; p-alanine aminotransferase, p-bilirubin, alkaline phosphatase and INR (international normalized ratio).
timeFrame: Baseline and Day 2,3,4
measure: Number of patients who develop coagulopathy defined as increase in INR (international normalized ratio) above the reference level.
timeFrame: Baseline and Day 2,3,4
measure: Presence of nausea under treatment measured by a VAS-scale (visual analogue scale).
timeFrame: Day 2,3,4
measure: Presence of oedema measured by weight in kg.
timeFrame: Day 2,3,4
measure: Causes of insufficient dietary intake, measured by a questionnaire filled out by the patient.
timeFrame: Day 2,3,4
measure: Presence of vomiting under treatment registered by patient reported cases.
timeFrame: Day 2,3,4
Locations:
city: Copenhagen
country: Denmark
facility: Clinic for Ear, Nose and Throat Surgery, Rigshospital
Study officials:
References: