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
Verified date | August 2016 |
Source | University of Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Dataprotection Agency |
Study type | Interventional |
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.
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Clinic for Ear, Nose and Throat Surgery, Rigshospital | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Jens Rikardt Andersen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | plasma phosphate | measurements up till 4 hours after oral ingestion | 4 hours | No |
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