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 | Completed

• 1 other identifier: HKM refeeding
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Refeeding Syndrome

Keywords

Refeeding Syndrome; low sodium; slowly absorbed carbohydrates; hypopotassemia; hypophosphatemia

Outcome Measures

Primary Outcomes (1)

• Occurence of Refeeding events

  Measured by a decrease in plasma phosphate levels.

  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 Outcomes (4)

• Incidence of infections

  daily, starting from day of admission and until day 7 of the treatment period or until discharge from the hospital if before day 7

• Length of stay

  Number of days from admission until discharge from the hospital, assessed up to 6 month

• Amount of days admitted to a Intensive-care unit

  Number of days from admission until discharge from the Intensive-care unit, assessed up to 6 month

• Other complications than infections

  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 Outcomes (1)

• Nutritional status

  daily, starting from day of admission and until day 7 of the treatment period or until discharge from the hospital if before day 7

Study Arms (2)

Low sodium diet

EXPERIMENTAL

Low sodium diet

Dietary Supplement: Low sodium diet

Control

NO INTERVENTION

Standard diet regime

Interventions

Low sodium diet DIETARY_SUPPLEMENT

Low sodium diet

Low sodium diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Rigshospitalet

Copenhagen Ø, 2100, Denmark

Location

MeSH Terms

Conditions

Refeeding Syndrome; Hypokalemia; Hypophosphatemia

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Phosphorus Metabolism Disorders

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jens R. Andersen, MD, lektor

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: May 3, 2013
• Study Start: May 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

DK (1)