Refeeding Syndrome Clinical Trial
Official title:
The Prevention of Refeeding Syndrome by a Diet Regime in Patient With Head and Neck Cancer
NCT number | NCT01845922 |
Other study ID # | HKM refeeding |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2013 |
Est. completion date | February 2014 |
Verified date | November 2019 |
Source | University of Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen ø |
Lead Sponsor | Collaborator |
---|---|
University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Nutritional status | 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). | daily, starting from day of admission and until day 7 of the treatment period or until discharge from the hospital if before day 7 | |
Primary | 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 | Incidence of infections | Measured by infection events recorded in the medical journal. | 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 | Length of stay | Measured by number of days in the hospital | Number of days from admission until discharge from the hospital, assessed up to 6 month | |
Secondary | Amount of days admitted to a Intensive-care unit | Measured by number of days in the intensive-care unit | Number of days from admission until discharge from the Intensive-care unit, assessed up to 6 month | |
Secondary | Other complications than infections | Measured by thrombosis events and other complications recorded in the medical journal | daily, starting from day of admission and until day 7 of the treatment period or until discharge from the hospital if before day 7 |
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