Body Composition Analysis in Patients Undergoing Chemoembolization

Hepatocellular Carcinoma Clinical Trial

Official title:

Body Composition Analysis by Bioelectrical Impedance Vector Analysis in Patients With Hepatocellular Carcinoma Undergoing Chemoembolization.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777698
• Other study ID #: QMECR1
• Status: Completed
• Phase: N/A
• First received: January 21, 2013
• Last updated: June 7, 2016
• Start date: April 2012
• Est. completion date: March 2016

Study information

• Verified date: June 2016
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Hepatocellular carcinoma represents 80-90% of primary hepatic malignant tumors. 80% of patients with hepatocellular carcinoma are associated with cirrhosis.

Chemoembolization is a process in which a chemotherapeutic agent is deposited directly into the hepatic tumor where the principal artery is embolized.

Bioelectrical impedance bases its evaluation in a model where the body is conformed by two different compartments: fat mass and fat free mass.

Bioelectrical impedance is complemented by vectorial analysis, which is independent to the state of hydration and is helpful to monitor any changes in corporal composition. It can be used as a control for the interpretation of the bioelectrical impedance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with hepato-renal disease

• Patients with hepatocellular carcinoma that are put down to radiofrequency ablation

• Patients with depression or any psiquiatric disease.

• Patients that don't agree to participate in the project.

Exclusion Criteria:

• Patients with hepatocellular carcinoma that are put down to radiofrequency ablation

• Patients with depression or any psiquiatric disease.

• Patients that don't agree to participate in the project.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"	Mexico city

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in body composition	To evaluate any changes in corporal composition in patients undergoing chemoembolization.	1 hour before treatment, 2 weeks after treatment, and 1 month after treatment	No