NCT02073032

Brief Summary

The main objective of this observational survey was to determine the incidence rate of refeeding phenomena (RFF) (defined as any decline in p-phosphate) and RFS (defined as any decline in p-phosphate with additional development of any of the following clinical symptoms: oedema, confusion, dyspnoea, hypotension, arrhythmia, seizures) among recently admitted or referred HNC patients to the Department of Otorhinolaryngology for surgery. The second objective was to determine if informations at admittance could identify HNC patients at high risk of developing RFF and RFS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
Last Updated

February 27, 2014

Status Verified

February 1, 2014

Enrollment Period

6 months

First QC Date

February 24, 2014

Last Update Submit

February 26, 2014

Conditions

Keywords

Refeeding syndrome, risk factors, head and neck cancer

Outcome Measures

Primary Outcomes (1)

  • Decrease in plasma phosphate after start of feeding

    Plasma phosphate measured every day the initial day of feeding after admission

    1 week

Secondary Outcomes (1)

  • Occurence of relevant clinical symptoms along with a decrease in plasma phosphate

    1 week

Study Arms (1)

Head -Neck cancer patients, no intervention

Other: No intervention, only observation

Interventions

Head -Neck cancer patients, no intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Referred for surgery with head and neck cancer

You may qualify if:

  • Head and Neck Cancer

You may not qualify if:

  • Not able to understand and speak Danish, having severe dementia and/or renal impairment (women: p-creatinine \> 180 μmol/l, men: p-creatinine \> 200 μmol/l).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Ear, Nose and Throat Surgery, Rigshospital

Copenhagen, 2100 Cph OE, Denmark

Location

Related Publications (1)

  • Rasmussen SO, Kristensen MB, Wessel I, Andersen JR. Incidence and Risk Factors of Refeeding Syndrome in Head and Neck Cancer Patients-An Observational Study. Nutr Cancer. 2016 Nov-Dec;68(8):1320-1329. doi: 10.1080/01635581.2016.1225103. Epub 2016 Sep 28.

MeSH Terms

Conditions

Head and Neck NeoplasmsRefeeding Syndrome

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Senior Physician

Study Record Dates

First Submitted

February 24, 2014

First Posted

February 27, 2014

Study Start

February 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

February 27, 2014

Record last verified: 2014-02

Locations