Analysis of Body Composition in Patients With Hepatocellular Carcinoma in Radioablation
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Analysis of Body Composition by Bioelectrical Impedance in Patients With Hepatocellular Carcinoma (HCC) Undergoing Treatment Radioablation|
- Nutritional Status [ Time Frame: Participants will be evaluated for a month ] [ Designated as safety issue: No ]Measured with the following parameters:body weight and height (to calculate BMI), triceps skinfold and mid-arm circumference (to calculated mid-arm muscle circumference, fat mass, fat free mass total, intracellular and extracellular body water obtained by bioelectrical impedance analysis and individual vectors obtained by bioelectrical impedance vector analysis.
- Minimal hepatic encephalopathy [ Time Frame: Participants will be assessed for one month ] [ Designated as safety issue: No ]Assessed by psychometric Hepatic Encephalopathy (PHES) and Critical Flicker Frequency (CFF)
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: HCC under treatment with radioablation
Assessment of nutritional status by anthropometry, bioelectrical impedance, blood sampling and application of psychometric hepatic encephalopathy score and critical flicker frequency, to assess the presence of hepatic encephalopathy.
Behavioral: HCC under treatment with radioablation
The evaluation will take place over a period of 30 days.
There will be a prospective, longitudinal, comparative. It included 20 patients diagnosed with hepatocellular carcinoma. As there are a finite number of active patients at the institute, and no studies with sample size well established, has seen a sample size of 20 patients.
The duration of individual monitoring shall be one month to three visits (baseline, week 2 and week 4 after receiving the first radiofrequency ablation). Each visit will be a nutritional assessment including anthropometry, bioelectrical impedance, biochemical tests, Psychometric Hepatic Encephalopathy Score (PHES) and Critical Flicker Frequency (CFF).
Anthropometric measures to be taken are weight, height and arm circumference average.
Bioelectrical impedance will be using a single frequency impedance meter (425 to -50 KHz, Range 0 to 10,000) Bioelectrical Body Composition Analyzer Quantium II RJL Systems. The team measured the subjects' impedance, resistance, reactance and phase angle by Lean Body program provided by the manufacturer.
Hepatic encephalopathy be evaluated by testing PHES and was measured CFF, also also be measured ammonium, tumor necrosis factor, IL-1, IL-6, IL-10, renin angiotensin aldosterone.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744639
|Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán|
|Mexico City, D.f., Mexico, 14000|
|Principal Investigator:||Aldo Torre Delgadillo, M.D. M.Sc||INCMNSZ|