Analysis of Body Composition in Patients With Hepatocellular Carcinoma in Radioablation

Analysis of Body Composition by Bioelectrical Impedance in Patients With Hepatocellular Carcinoma (HCC) Undergoing Treatment Radioablation

Number of shows: 20 patients Track: A month with three visiting Intervention: Nutritional assessment including anthropometry, bioelectrical impedance, biochemical tests, Psychometric Hepatic Encephalopathy Score and Critical Flicker Frequency.

Study Overview

• Status: Withdrawn
• Conditions: Liver Carcinoma
• Intervention / Treatment: Behavioral: HCC under treatment with radioablation

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • D.f.
    • Mexico City, D.f., Mexico, 14000
      • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with a diagnosis of hepatocellular carcinoma, treatment-naive and who are referred to the radiology department for radioablation as first therapy.
• Outpatients.
• Willingness to participate in the project.

Exclusion Criteria:

• Patients with hepato-renal diseases.
• Patients diagnosed with hepatocellular carcinoma undergoing chemoembolization treatment, or who have received more than one session radioablation.
• Patients with depression or psychiatric illnesses
• Patients who do not agree to participate in the project.

Exclusion Criteria:

• incomplete Applied Tests
• disagreement of the person to perform any of the tests
• monitoring Breach
• Hospitalization or death after the first session radioablation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; Other Names: Anthropometry; Bioelectrical impedance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional Status	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.	Participants will be evaluated for a month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal hepatic encephalopathy	Assessed by psychometric Hepatic Encephalopathy (PHES) and Critical Flicker Frequency (CFF)	Participants will be assessed for one month

Collaborators and Investigators

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: December 5, 2012
• First Submitted That Met QC Criteria: December 5, 2012
• First Posted (Estimate): December 7, 2012

Study Record Updates

• Last Update Posted (Estimate): June 8, 2016
• Last Update Submitted That Met QC Criteria: June 7, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Hepatocellular carcinoma; Radioablation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: GAS 720-12/13-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No