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The Prevention of Refeeding Syndrome by a Diet Regime in Patient With Head and Neck Cancer

Phase 4
18 Years
Open (Enrolling)
Refeeding Syndrome

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Trial Information

The Prevention of Refeeding Syndrome by a Diet Regime in Patient With Head and Neck Cancer

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.

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

- 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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Occurence of Refeeding events

Outcome Description:

Measured by a decrease in plasma phosphate levels.

Outcome 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

Safety Issue:


Principal Investigator

Jens R. Andersen, MD, lektor

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Copenhagen


Denmark: The Ministry of the Interior and Health

Study ID:

HKM refeeding



Start Date:

May 2013

Completion Date:

February 2014

Related Keywords:

  • Refeeding Syndrome
  • Refeeding Syndrome
  • low sodium
  • slowly absorbed carbohydrates
  • hypopotassemia
  • hypophosphatemia
  • Head and Neck Neoplasms
  • Refeeding Syndrome