Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients

Not Applicable

Completed

• Conditions: Head and Neck Neoplasm
• Interventions: Other: Parenteral Nutrition

• Registration Number: NCT03042195
• Lead Sponsor: University of Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-08
• Study Start: 2016-12-18
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-03
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-09
• Last Update Posted: 2018-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Parenteral Nutrition	Supplementary parenteral nutrition

Primary Outcome Measures

Name	Time	Method
Postoperative Infectious Complications	At day 30	Local and systemic
Postoperative Thrombotic Complications	At day 30

Secondary Outcome Measures

Name	Time	Method
Fistula formation without infection defined by journal documentation	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)
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.	Day 2,3,4	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.	Day 2,3,4	Data will be collected from the patient's record.
Length of stay at the hospital	Up to 30 days
Coverage of energy requirement, estimated by the Harris Benedict formula. Coverage is estimated by daily dietary registration.	Day 1,2,3,4
Coverage of protein requirement, estimated in g/kg/day. The coverage is estimated by daily dietary registration.	Day 1,2,3, 4
Hand Grip Strength measured by a hand grip strength dynamometer in kilograms.	Baseline and Day 2,3,4

Trial Locations

Locations (1)

Clinic for Ear, Nose and Throat Surgery, Rigshospital; 🇩🇰 Copenhagen, Denmark