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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

Primary Purpose

Refeeding Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Low sodium diet
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Refeeding Syndrome focused on measuring Refeeding Syndrome, low sodium, slowly absorbed carbohydrates, hypopotassemia, hypophosphatemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • authoritative
  • written consent
  • suspected of or diagnosed with head and neck cancer
  • Increased risk of Refeeding syndrome, defined by one of the below:
  • A-score of 1 in the Nutritional Risk Screening 2002 (NRS 2002)
  • high levels of alcohol consumption (men>168g alcohol/week corresponding to approximately 14 units, women>84g alcohol/week corresponding to approximately 7 units)
  • anamnesis with prior radiation therapy
  • Head and neck pain that require pain management or inhibits food intake
  • the presence of problems with eating that are so serious that the food intake is inhibited

Exclusion Criteria:

  • minor or declared incapable of managing own affairs
  • patients that are incapable of understanding and communicating in Danish
  • patients with dementia
  • if the patient is not diagnosed with head and neck cancer

Sites / Locations

  • Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Low sodium diet

Control

Arm Description

Low sodium diet

Standard diet regime

Outcomes

Primary Outcome Measures

Occurence of Refeeding events
Measured by a decrease in plasma phosphate levels.

Secondary Outcome Measures

Incidence of infections
Measured by infection events recorded in the medical journal.
Length of stay
Measured by number of days in the hospital
Amount of days admitted to a Intensive-care unit
Measured by number of days in the intensive-care unit
Other complications than infections
Measured by thrombosis events and other complications recorded in the medical journal

Full Information

First Posted
April 22, 2013
Last Updated
November 11, 2019
Sponsor
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01845922
Brief Title
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
Official Title
The Prevention of Refeeding Syndrome by a Diet Regime in Patient With Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
A large weight loss as a result of a longer period (>30 days) of starvation or semi-starvation will result in a metabolic adaptation to the decreased food intake. To prevent the degradation of muscle mass into gluco- and ketogenic amino acids to be used for energy production, a shift from gluconeogenesis to lipolysis occurs. Lipids therefore become the primary energy fuel, and the body adapts to use ketone bodies instead of glucose. The reduction in glucose metabolism results in a decreased need for amino acids for use in gluconeogenesis. This means that less amino acids are needed for gluconeogenesis and therefore important muscle mass is preserved. At the same time as the lipid stores are degraded, an intracellular depletion of phosphate, potassium and magnesium occurs. The serum levels of these electrolytes stay within the normal range as long as the body is in the adaptive starvation state. A too quick reintroduction of food to the body will result in a major glucose-induced increase in insulin secretion that will stimulate the transport of glucose, phosphate, potassium and magnesium from plasma into the cells. Because the extracellular blood volume is much smaller than the intracellular, an influx of these electrolytes to the intracellular space will result in a quick and large decrease in the plasma levels. Likewise, an influx of glucose means that it again can enter the glucolysis, and the need for phosphate and the co-factor thiamine, for the production of ATP, will increase. The increased production of adenosine triphosphate (ATP) will activate membrane pumps and reestablish the membrane potential. This means that sodium will be transported from the large intracellular space to the small extracellular, with subsequent fluid retention and edema formation. Therefore a slowly introduced diet low in sodium and high in slowly absorbed carbohydrates might prevent the development of refeeding syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refeeding Syndrome
Keywords
Refeeding Syndrome, low sodium, slowly absorbed carbohydrates, hypopotassemia, hypophosphatemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low sodium diet
Arm Type
Experimental
Arm Description
Low sodium diet
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard diet regime
Intervention Type
Dietary Supplement
Intervention Name(s)
Low sodium diet
Intervention Description
Low sodium diet
Primary Outcome Measure Information:
Title
Occurence of Refeeding events
Description
Measured by a decrease in plasma phosphate levels.
Time Frame
daily, starting from day of admission and until day 7 of the treatment period or until discharge from the hospital if before day 7
Secondary Outcome Measure Information:
Title
Incidence of infections
Description
Measured by infection events recorded in the medical journal.
Time Frame
daily, starting from day of admission and until day 7 of the treatment period or until discharge from the hospital if before day 7
Title
Length of stay
Description
Measured by number of days in the hospital
Time Frame
Number of days from admission until discharge from the hospital, assessed up to 6 month
Title
Amount of days admitted to a Intensive-care unit
Description
Measured by number of days in the intensive-care unit
Time Frame
Number of days from admission until discharge from the Intensive-care unit, assessed up to 6 month
Title
Other complications than infections
Description
Measured by thrombosis events and other complications recorded in the medical journal
Time Frame
daily, starting from day of admission and until day 7 of the treatment period or until discharge from the hospital if before day 7
Other Pre-specified Outcome Measures:
Title
Nutritional status
Description
Measured by changes in plasma cobalamin levels/vitamin B12 levels (pmol/L), plasma iron levels (μmol/L), plasma ferritin levels (μg/L), mean cell volume (MCV) (fL), plasma albumin levels (μmol/L), plasma alanine aminotransferase levels (ALAT) (U/L), plasma coagulation factors II, VII, X levels (INR), plasma c-reactive protein levels (nmol/L), hemoglobin levels (Hgb) (mmol/L), plasma sodium levels (mmol/L), plasma potassium levels (mmol/L), plasma creatinine levels (μmol/L), plasma carbamide levels (mmol/L), plasma folate levels (nmol/L), plasma zink levels (μmol/L), plasma magnesium levels (mmol/L) and plasma selenium levels (μg/L).
Time Frame
daily, starting from day of admission and until day 7 of the treatment period or until discharge from the hospital if before day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: authoritative written consent suspected of or diagnosed with head and neck cancer Increased risk of Refeeding syndrome, defined by one of the below: A-score of 1 in the Nutritional Risk Screening 2002 (NRS 2002) high levels of alcohol consumption (men>168g alcohol/week corresponding to approximately 14 units, women>84g alcohol/week corresponding to approximately 7 units) anamnesis with prior radiation therapy Head and neck pain that require pain management or inhibits food intake the presence of problems with eating that are so serious that the food intake is inhibited Exclusion Criteria: minor or declared incapable of managing own affairs patients that are incapable of understanding and communicating in Danish patients with dementia if the patient is not diagnosed with head and neck cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens R. Andersen, MD, lektor
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen ø
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

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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

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