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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Copenhagen
Sponsor:
Information provided by (Responsible Party):
AAstrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01845922
First received: April 22, 2013
Last updated: May 5, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Refeeding Syndrome
Dietary Supplement: Low sodium diet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Prevention of Refeeding Syndrome by a Diet Regime in Patient With Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Measured by a decrease in plasma phosphate levels.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured by thrombosis events and other complications recorded in the medical journal


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 52
Study Start Date: May 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low sodium diet
Low sodium diet
Dietary Supplement: Low sodium diet
Low sodium diet
No Intervention: Control
Standard diet regime

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01845922

Contacts
Contact: Jens R. Andersen, Assoc Prof +4523346654 jra@life.ku.dk

Locations
Denmark
Rigshospitalet Recruiting
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         
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: Jens R. Andersen, MD, lektor University of Copenhagen
  More Information

No publications provided

Responsible Party: AAstrup, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01845922     History of Changes
Other Study ID Numbers: HKM refeeding
Study First Received: April 22, 2013
Last Updated: May 5, 2013
Health Authority: Denmark: The Ministry of the Interior and Health
Denmark: The National Committee on Health Research Ethics

Keywords provided by University of Copenhagen:
Refeeding Syndrome
low sodium
slowly absorbed carbohydrates
hypopotassemia
hypophosphatemia

Additional relevant MeSH terms:
Head and Neck Neoplasms
Refeeding Syndrome
Neoplasms by Site
Neoplasms
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on August 18, 2014