Absorption of Orally Ingested Phosphate in Refeeding Syndrome

Cancer of the Head and Neck Clinical Trial

Official title:

Absorption of Orally Ingested Phosphate in Head and Neck Cancer Patients With and Without Refeeding Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02880072
• Other study ID #: H-6-2013-001
• Status: Completed
• Phase: Phase 4
• First received: August 23, 2016
• Last updated: August 25, 2016
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: August 2016
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

A phosphate supplement is part of the treatment of patients with the refeeding syndrome (RFS). It is not known, if the generalized edema also affects the intestine to decrease absorption. The aim was to investigate, if oral treatment is possible in mild to moderate RFS. In a randomized crossover design 12 hospitalized head-neck cancer patients ingested four oral solutions of phosphate in two-day periods. In a low-dose period the investigators compared five mmol phosphate from either skimmed milk or Di-sodiumphosphate-di-hydrate and potassium di-hydrogens-phosphate with black currant flavor (PBC), and in a high-dose period 20 mmol from either Addiphos® or the PBC-solution. P-phosphate was measured two and four hours after the ingestion, the urinary excretion after four hours.

P-phosphate significantly increased after PBC in both the low- and high-dose and Addiphos®, but not after skimmed milk. The increase was larger after Addiphos® than the PBC-solution. There was no difference in the increase between the patients with low p-phosphate and those with normal values, and no correlation between baseline p-phosphate and percent increase. There was no group difference in the urinary excretion of phosphate. The investigators conclude that phosphate can be readily absorbed after oral administration, but skimmed milk can´t be recommend for this purpose.

Description:

The study was designed as a non-blinded, randomized, controlled crossover intervention study.

A total of 12 hospitalized adult head-neck cancer patients, 11 men and one woman, gave informed consent to participate. Six patients with a p-phosphate between 0.30-0.80 mmol/l were included as well as six patients (controls) with a p-phosphate in the normal range of 0.80-1.50 mmol/l. The control patients matched the hypophosphatemic patients regarding sex, age (± 10 years) and alcohol habits. Patients with diagnosed renal failure, edema, diabetes, liver failure, gastrointestinal disorders, pregnant and lactating women were excluded. None of the patients had phosphate supplementation within the previous 24 h. Randomization determined the order of the phosphate supplements divided into low-doses of five mmol followed by high-dose 20 mmol both for two day periods. Accordingly, four days intervention with a different phosphate supplement every day.

In the low-dose period supplements consisted of a daily dose of five mmol phosphate from skimmed milk (97 mg phosphorus and 0.1 g fat/100 ml) or Phosphate with black currant flavor (PBC) (disodiumphosphatedihydrate and potassiumdihydrogenphosphate, 1 mmol phosphate/ml). In the high-dose period supplements consisted of 20 mmol phosphate from Addiphos® (Fresenius-Kabi) (disodiumphosphate, potassiumdihydrogenphosphate, potassiumhydroxide, 2 mmol/ml) and PBC. The patients fasted six hours prior to baseline blood- and urine samples and during the four hours of the trial. Blood samples were repeated after two and four hours, urine after four hours. The interval between blood samples was determined on the basis of an animal experiment, which described phosphate absorption measured in plasma 1 hour after administration (10). The interval was extended to 2 hours due to the risk of gastric retention.

The primary outcome was the changes in p-phosphate. The secondary outcomes were changes in u-phosphate and changes in p-potassium, p-magnesium and p-sodium. The paired data were tested by the Wilcoxon test. Non paired data were tested by the Mann-Whitney test. Spearman-rank correlation test was used, and the statistical analyses were performed with STATA version 13.1 (StataCorp LP, USA, Texas).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Head and Neck cancer diagnosed + informed consent

Exclusion Criteria:

• Severe organ failure, pregnancy, lactating women, in treatment with phosphate, unable to communicate sufficiently to understand the investigation

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer of the Head and Neck
• Head and Neck Neoplasms
• Refeeding Syndrome
• Syndrome

Intervention

Dietary Supplement:
• phosphate orally
4 different preparations of phosphate

Locations

Country	Name	City	State
Denmark	Clinic for Ear, Nose and Throat Surgery, Rigshospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Jens Rikardt Andersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma phosphate	measurements up till 4 hours after oral ingestion	4 hours	No