Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients

NCT03042195 | Completed

• 1 other identifier: H-16042979
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Neoplasm

Keywords

Supplementary Parenteral Nutrition; Postoperative Nutrition; Postoperative complications

Outcome Measures

Primary Outcomes (2)

• Postoperative Infectious Complications

  Local and systemic

  At day 30

• Postoperative Thrombotic Complications

  At day 30

Secondary Outcomes (7)

• Fistula formation without infection defined by journal documentation

  Day 1,2,3,4,7,14, 23 and 30

• 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

• 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

• 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

Other Outcomes (6)

• Biochemical Changes in Liver Parameters; p-alanine aminotransferase, p-bilirubin, alkaline phosphatase and INR (international normalized ratio).

  Baseline and Day 2,3,4

• Number of patients who develop coagulopathy defined as increase in INR (international normalized ratio) above the reference level.

  Baseline and Day 2,3,4

• Presence of nausea under treatment measured by a VAS-scale (visual analogue scale).

  Day 2,3,4

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Supplementary parenteral nutrition

Other: Parenteral Nutrition

Control group

NO INTERVENTION

The control group will receive standard nutritional care

Interventions

Parenteral Nutrition OTHER

Supplementary parenteral nutrition to achieve 100% coverage of estimated needs

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with allergy to components in parenteral nutrition
• Patients where it is impossible to give parenteral nutrition

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Clinic for Ear, Nose and Throat Surgery, Rigshospital

Copenhagen, 2100 Cph OE, Denmark

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Postoperative Complications

Interventions

Parenteral Nutrition

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: February 3, 2017
• Study Start: December 18, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 10, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)