Analysis of Body Composition in Patients With Hepatocellular Carcinoma in Radioablation
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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 |
- 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)
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (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:
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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 |
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| Contact: Aldo Torre, M.D. M.Sc | 54870900 ext 2709 | detoal@yahoo.com |
| 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 | |
| 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 5, 2012 |
| 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 May 19, 2013