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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|ClinicalTrials.gov Identifier: NCT01845922|
Recruitment Status : Unknown
Verified May 2013 by AAstrup, University of Copenhagen.
Recruitment status was: Recruiting
First Posted : May 3, 2013
Last Update Posted : May 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Refeeding Syndrome||Dietary Supplement: Low sodium diet||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Prevention of Refeeding Syndrome by a Diet Regime in Patient With Head and Neck Cancer|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||February 2014|
|Estimated Study Completion Date :||February 2014|
Experimental: Low sodium diet
Low sodium diet
Dietary Supplement: Low sodium diet
Low sodium diet
No Intervention: Control
Standard diet regime
- Occurence of Refeeding events [ 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 ]Measured by a decrease in plasma phosphate levels.
- Incidence of infections [ 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 ]Measured by infection events recorded in the medical journal.
- Length of stay [ Time Frame: Number of days from admission until discharge from the hospital, assessed up to 6 month ]Measured by number of days in the hospital
- Amount of days admitted to a Intensive-care unit [ Time Frame: Number of days from admission until discharge from the Intensive-care unit, assessed up to 6 month ]Measured by number of days in the intensive-care unit
- Other complications than infections [ 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 ]Measured by thrombosis events and other complications recorded in the medical journal
- Nutritional status [ 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 ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845922
|Contact: Jens R. Andersen, Assoc Proffirstname.lastname@example.org|
|Copenhagen ø, Denmark, 2100|
|Contact: Irene Wessel, MD, Phd 004535458322|
|Sub-Investigator: Katrine B. Dester, M.S. student|
|Sub-Investigator: Henrik Carlsen, M.S. student|
|Sub-Investigator: Martine D. Hansen, M.S. student|
|Principal Investigator:||Jens R. Andersen, MD, lektor||University of Copenhagen|