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The Effect of a Diet Based on Low Sodium and Slowly Absorbed Carbohydrates on the Incidence of Refeeding Syndrome in Patients With Head and Neck Cancer

NCT01845922 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-11-13

No results posted yet for this study

Summary

The study is based on a master thesis which showed that 72% of patients with head and neck cancer admitted to a Danish hospital (Rigshospitalet, Copenhagen) developed refeeding syndrome after admission.

Refeeding syndrome is characterized by a decrease in plasma phosphate levels, which develops after the reintroduction of an adequate food intake after a longer period of starvation or semi-starvation. This normally happens within 7 days after reintroduction of food.

The aim of this study is to minimize the incidence of refeeding syndrome in this group of patients by reintroducing food slowly and by providing a diet low in sodium and high in slowly absorbed carbohydrates as a prevention diet (i.e. given before a potential decrease in plasma phosphate levels appear). Both patients that eat normally, patients with eating tubes and patients with central vein catheters are included in the study, but the data will be evaluated both together and separately.

Conditions

  • Refeeding Syndrome

Interventions

DIETARY_SUPPLEMENT

Low sodium diet

Low sodium diet

Sponsors & Collaborators

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Jens R. Andersen, MD, lektor · University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Denmark

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01845922 on ClinicalTrials.gov