Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Head and Neck Neoplasm

Intervention / Treatment
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* Other: Parenteral Nutrition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>Supplementary parenteral nutrition | Other: Parenteral Nutrition<br>* Supplementary parenteral nutrition to achieve 100% coverage of estimated needs<br>|
| No Intervention: Control group<br>The control group will receive standard nutritional care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Infectious Complications | Local and systemic | At day 30 | 
| Postoperative Thrombotic Complications |  | At day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supplementary Parenteral Nutrition, Postoperative Nutrition, Postoperative complications