Clinical trial · Interventional
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
The Prevention of Refeeding Syndrome by a Diet Regime in Patient With Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refeeding Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low sodium diet | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Low sodium diet
- description
- Low sodium diet
- interventionNames
- Dietary Supplement: Low sodium diet
- type
- NO_INTERVENTION
- label
- Control
- description
- Standard diet regime
Primary outcomes (1)
- measure
- Occurence of Refeeding events
- timeFrame
- daily, starting from day of admission and until day 7 of the treatment period or until discharge from the hospital if before day 7
- description
- Measured by a decrease in plasma phosphate levels.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available