Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients

Head and Neck Neoplasm Clinical Trial

— SpPN-HNC  

Official title:

Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients - A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03042195
• Other study ID #: H-16042979
• Status: Completed
• Phase: N/A
• First received: December 8, 2016
• Last updated: April 9, 2018
• Start date: December 18, 2016
• Est. completion date: September 2017

Study information

• Verified date: April 2018
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasm
• Head and Neck Neoplasms

Intervention

Other:
• Parenteral Nutrition
Supplementary parenteral nutrition to achieve 100% coverage of estimated needs

Locations

Country	Name	City	State
Denmark	Clinic for Ear, Nose and Throat Surgery, Rigshospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biochemical Changes in Liver Parameters; p-alanine aminotransferase, p-bilirubin, alkaline phosphatase and INR (international normalized ratio).		Baseline and Day 2,3,4
Other	Number of patients who develop coagulopathy defined as increase in INR (international normalized ratio) above the reference level.		Baseline and Day 2,3,4
Other	Presence of nausea under treatment measured by a VAS-scale (visual analogue scale).		Day 2,3,4
Other	Presence of oedema measured by weight in kg.		Day 2,3,4
Other	Causes of insufficient dietary intake, measured by a questionnaire filled out by the patient.		Day 2,3,4
Other	Presence of vomiting under treatment registered by patient reported cases.		Day 2,3,4
Primary	Postoperative Infectious Complications	Local and systemic	At day 30
Primary	Postoperative Thrombotic Complications		At day 30
Secondary	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)	Day 1,2,3,4,7,14, 23 and 30
Secondary	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.	Day 2,3,4
Secondary	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.	Day 2,3,4
Secondary	Length of stay at the hospital		Up to 30 days
Secondary	Coverage of energy requirement, estimated by the Harris Benedict formula. Coverage is estimated by daily dietary registration.		Day 1,2,3,4
Secondary	Coverage of protein requirement, estimated in g/kg/day. The coverage is estimated by daily dietary registration.		Day 1,2,3, 4
Secondary	Hand Grip Strength measured by a hand grip strength dynamometer in kilograms.		Baseline and Day 2,3,4