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Analysis of Body Composition in Patients With Hepatocellular Carcinoma in Radioablation

This study has been withdrawn prior to enrollment.
(Unable to find patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01744639
First Posted: December 7, 2012
Last Update Posted: June 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  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: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Analysis of Body Composition by Bioelectrical Impedance in Patients With Hepatocellular Carcinoma (HCC) Undergoing Treatment Radioablation

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

Primary Outcome Measures:
  • Nutritional Status [ Time Frame: Participants will be evaluated for a month ]
    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 ]
    Assessed by psychometric Hepatic Encephalopathy (PHES) and Critical Flicker Frequency (CFF)


Enrollment: 0
Study Start Date: December 2012
Study Completion Date: May 2016
Primary Completion Date: December 2015 (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

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744639


Locations
Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, D.f., Mexico, 14000
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

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
First Submitted: December 5, 2012
First Posted: December 7, 2012
Last Update Posted: June 8, 2016
Last Verified: June 2016

Keywords provided by ALDO TORRE DELGADILLO, 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