Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients

NCT ID: NCT03042195

Last Updated: 2018-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-18

Study Completion Date

2017-09-30

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.

Detailed Description

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Conditions

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Head and Neck Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group

Supplementary parenteral nutrition

Group Type ACTIVE_COMPARATOR

Parenteral Nutrition

Intervention Type OTHER

Supplementary parenteral nutrition to achieve 100% coverage of estimated needs

Control group

The control group will receive standard nutritional care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Parenteral Nutrition

Supplementary parenteral nutrition to achieve 100% coverage of estimated needs

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Jens Rikardt Andersen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinic for Ear, Nose and Throat Surgery, Rigshospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-16042979

Identifier Type: -

Identifier Source: org_study_id

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