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Completed

NCT Number: NCT03042195

Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients

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.

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Key information

Conditions

Head and Neck Neoplasm Head and Neck Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic for Ear, Nose and Throat Surgery, Rigshospital

Copenhagen, 2100 Cph OE, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parenteral nutrition

Other

Supplementary parenteral nutrition to achieve 100% coverage of estimated needs

Primary outcomes

  1. Postoperative Infectious Complications

    Time frame: At day 30

    Local and systemic

  2. Postoperative Thrombotic Complications

    Time frame: At day 30

Secondary outcomes

  1. Fistula formation without infection defined by journal documentation

    Time frame: 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)

  2. 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.

    Time frame: Day 2,3,4

    Data are collected from the patient's record.

  3. 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.

    Time frame: Day 2,3,4

    Data will be collected from the patient's record.

  4. Length of stay at the hospital

    Time frame: Up to 30 days

  5. Coverage of energy requirement, estimated by the Harris Benedict formula. Coverage is estimated by daily dietary registration.

    Time frame: Day 1,2,3,4

  6. Coverage of protein requirement, estimated in g/kg/day. The coverage is estimated by daily dietary registration.

    Time frame: Day 1,2,3, 4

  7. Hand Grip Strength measured by a hand grip strength dynamometer in kilograms.

    Time frame: Baseline and Day 2,3,4

Other outcomes

  1. 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

  2. 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

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

    Time frame: Day 2,3,4

  4. Presence of oedema measured by weight in kg.

    Time frame: Day 2,3,4

  5. Causes of insufficient dietary intake, measured by a questionnaire filled out by the patient.

    Time frame: Day 2,3,4

  6. Presence of vomiting under treatment registered by patient reported cases.

    Time frame: Day 2,3,4

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

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

Acronym: SpPN-HNC

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 3, 2017
Registry last updated
Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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