Analysis of Body Composition in Patients With Hepatocellular Carcinoma in Radioablation

This study is currently recruiting participants.
Verified December 2013 by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor:
Information provided by (Responsible Party):
ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT01744639
First received: December 5, 2012
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Liver Carcinoma
Behavioral: HCC under treatment with radioablation

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744639

Contacts
Contact: Aldo Torre, M.D. M.Sc 54870900 ext 2709 detoal@yahoo.com

Locations
Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Recruiting
Mexico City, D.f., Mexico, 14000
Contact: Aldo Torre Delgadillo, M.D. M.Sci    54870900 ext 2709    detoal@yahoo.com   
Contact: Ariadna Karen Flores Balbuena, LN    54870900 ext 2709    nut.ariadnakaren@hotmail.com   
Principal Investigator: Aldo Torre Delgadillo, MDMSci         
Sub-Investigator: Ariadna Karen Flores Balbuena, LN         
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
Principal Investigator: Aldo Torre Delgadillo, M.D. M.Sc INCMNSZ
  More Information

No publications provided

Responsible Party: ALDO TORRE DELGADILLO, Investigador Principal, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT01744639     History of Changes
Other Study ID Numbers: GAS 720-12/13-1
Study First Received: December 5, 2012
Last Updated: December 16, 2013
Health Authority: Mexico: Secretaria de Salud

Keywords provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Hepatocellular carcinoma
Radioablation

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on April 23, 2014