Cancer of the Head and Neck Clinical Trial
Official title:
Incidence and Risk Factors of Refeeding Syndrome in Head and Neck Cancer Patients - An Observational Study
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.
Consecutive patients referred to the Department of Otorhinolaryngology and Audiology on
suspicion of cancer during the study period from February to August 2011. Patients were
asked for participation if they met the following inclusion criteria: age ≥ 18 years,
suspicion or diagnosis with HNC, and first time referral. Patients were excluded 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).
Every participant was observed for eight days after admission or referral to the clinic.
Blood samples and interviews were performed at baseline and at day 2, 4 and 7.
Potential factors defining high risk were analyzed by comparing those patients developing
RFS or RFF with those that did not. Baseline information consisted of data from the
interview and supplemental information in medical records. As a part of the interview, the
participant was asked about dietary history in order to assess daily habitual energy end
protein intake. Hand grip strength (HGS) was measured, and the participant performed a
maximal step test on a 20 cm high bench. The nutritional status was evaluated using the
NRS-2002 screening tool (13) and refeeding risk according to the NICE-guidelines (14).
Intake of energy, protein, and fluids was registered and compared to the estimated
requirements. Standardized questionnaires were used for the interviews, and blood samples
were analyzed as part of daily routine in in-patients, while outpatients had their blood
samples collected by their general practitioner or by accredited hospital laboratories close
to their homes. For participants with a body mass index (BMI) < 30 kg/m2, energy requirement
was calculated using Harris & Benedict's equations for men and women respectively (15). A
physical activity factor of 1.1 for bedridden participants and 1.3 for non-bedridden
participants was used. Protein requirement was calculated as 18 E-% of total energy
requirement. For participants with a BMI ≥ 30 kg/m2 the following equations were used:
Energy requirement (bedridden) = 85 kJ/kg body weight/day, energy requirement
(non-bedridden) = 100kJ/kg body weight/day, protein requirement (bedridden) = 0.9 g/kg body
weight/day, protein requirement (non-bedridden) = 1.1 g/kg body weight/day (16). Energy and
protein intake was estimated from the 24-hour dietary recall by using the computer program
"Dankost 3000" (Dankost 3000, version 2.5, Danish Catering Center, Herlev, Denmark).
For the step test, an audio file was used to dictate the rhythm, similar to the audio file
used in The Danish Step Test (17). HGS was measured on the right hand with a hydraulic
Jamar® hand dynamometer (scale 0-200 lbs). Three measurements were conducted with a break of
15 seconds between each measurement, and the mean value was used for analysis. Head and neck
pain were measured twice by visual analogue scale (VAS) (18) with added marks for consistent
pain and for pain during eating.
All statistical analyses were performed using STATA/IC 10.0 for Windows and Microsoft Excel
2003. The Mann-Whitney rank sum test was used for group comparisons, and dose-response
relationships were tested by the Spearman's rank correlation test. Potential risk factors
were analyzed by the Chi2-test with Yates correction or the Fisher's exact test as
appropriate.
The primary outcomes were changes in p-phosphate and the development of RFS-symptoms after
start of nutritional intake. A discriminative value for a clinically relevant
hypophosphatemia or decline in p-phosphate was estimated from the coherence between the
development of clinical symptoms and the lowest p-phosphate as well as the change in
p-phosphate from baseline to the study day with the lowest p-phosphate value.
In case of significant differences between groups, odds ratios (OR) were calculated and
Spearman's rank correlation test was used to test for correlation between the potential risk
factor and change in p-phosphate, and correlations were tested for linearity by linear
regression analysis. Sensitivity, specificity, and predictive values were calculated for
NRS-2002 total score ≥ 3, NRS-2002 A-score = 1 and NICE guidelines, respectively.
The maximal increase in energy intake to be allowed without causing RFS was analyzed by
correlating changes in p-phosphate and changes in intake in percentage of calculated energy
requirements.
;
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04444869 -
Testing Less Intensive Radiation With Chemotherapy to Treat Low-risk Patients With HPV-positive Oropharyngeal Cancer
|
Phase 2 | |
Terminated |
NCT01370876 -
Efficacy and Safety Study of Oxaliplatin/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer
|
Phase 2 | |
Terminated |
NCT03297957 -
Fluorescence Imaging in Head and Neck Cancer
|
N/A | |
Completed |
NCT00716157 -
Incidence and Patterns of Nausea/Vomiting With Combined Chemotherapy and Radiation
|
N/A | |
Recruiting |
NCT04880148 -
The Effectiveness of a Thyme and Honey Spray for Oral Toxicities
|
N/A | |
Completed |
NCT01017224 -
DAHANCA 24: Prognostic Value of 18F-FAZA in Head and Neck Squamous Cell Carcinoma (HNSCC)
|
N/A | |
Completed |
NCT00798655 -
Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer
|
Phase 2 | |
Completed |
NCT00496652 -
DAHANCA 19: The Importance of the EGFr-inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC
|
Phase 3 | |
Recruiting |
NCT03620084 -
Effects of Expiratory Muscle Strength Training on Airway Protection and Swallowing in Chronic Dysphagia After Radiation Therapy
|
N/A | |
Completed |
NCT00147472 -
Positronic Emission Tomography (PET) Imaging in Post Radiation Evaluation of Head and Neck Tumours (PET PREVENT Trial)
|
Phase 3 | |
Completed |
NCT02880072 -
Absorption of Orally Ingested Phosphate in Refeeding Syndrome
|
Phase 4 | |
Completed |
NCT01917942 -
Radiotherapy With Humidification in Head And Neck Cancer
|
Phase 3 | |
Recruiting |
NCT04865731 -
Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer
|
Phase 2 | |
Completed |
NCT02442336 -
A Web-Based Multimedia Intervention for Head and Neck Cancer Patients
|
N/A | |
Completed |
NCT03102229 -
Real-time Activity Monitoring to Prevent Admissions During RadioTherapy
|
N/A | |
Completed |
NCT00474825 -
Dose Escalation Study of Hyperbaric Oxygen With Radiation and Chemotherapy to Treat Squamous Cell Carcinoma of the Head and Neck
|
Phase 1 | |
Recruiting |
NCT00180921 -
Study of Imatinib (Glivec) in Patients With Adenoid Cystic Carcinoma of the Head and Neck
|
Phase 2 | |
Completed |
NCT01283334 -
A Study of Carboplatin, Cetuximab and RAD001 in Advanced Head and Neck Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT02557048 -
Head and Neck Cancer in Children: A Retrospective Study
|
||
Active, not recruiting |
NCT02270814 -
Cisplatin, Nab-Paclitaxel, and Cetuximab (CACTUX) in Patients With Incurable Head and Neck Squamous Cell Carcinoma
|
Phase 2 |