Analysis of Body Composition in Patients With Hepatocellular Carcinoma in Radioablation
Primary Purpose
Liver Carcinoma
Status
Withdrawn
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
HCC under treatment with radioablation
Sponsored by
About this trial
This is an interventional diagnostic trial for Liver Carcinoma focused on measuring Hepatocellular carcinoma, Radioablation
Eligibility 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.
Sites / Locations
- Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HCC under treatment with radioablation
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Minimal hepatic encephalopathy
Assessed by psychometric Hepatic Encephalopathy (PHES) and Critical Flicker Frequency (CFF)
Full Information
NCT ID
NCT01744639
First Posted
December 5, 2012
Last Updated
June 7, 2016
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1. Study Identification
Unique Protocol Identification Number
NCT01744639
Brief Title
Analysis of Body Composition in Patients With Hepatocellular Carcinoma in Radioablation
Official Title
Analysis of Body Composition by Bioelectrical Impedance in Patients With Hepatocellular Carcinoma (HCC) Undergoing Treatment Radioablation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to find patients
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Carcinoma
Keywords
Hepatocellular carcinoma, Radioablation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HCC under treatment with radioablation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HCC under treatment with radioablation
Other Intervention Name(s)
Anthropometry, Bioelectrical impedance
Intervention Description
The evaluation will take place over a period of 30 days.
Primary Outcome Measure Information:
Title
Nutritional Status
Description
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.
Time Frame
Participants will be evaluated for a month
Secondary Outcome Measure Information:
Title
Minimal hepatic encephalopathy
Description
Assessed by psychometric Hepatic Encephalopathy (PHES) and Critical Flicker Frequency (CFF)
Time Frame
Participants will be assessed for one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aldo Torre Delgadillo, M.D. M.Sc
Organizational Affiliation
INCMNSZ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
City
Mexico City
State/Province
D.f.
ZIP/Postal Code
14000
Country
Mexico
12. IPD Sharing Statement
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Analysis of Body Composition in Patients With Hepatocellular Carcinoma in Radioablation
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