Body Composition Analysis in Patients Undergoing Chemoembolization

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 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:
NCT01777698
First received: January 21, 2013
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition
Hepatocellular Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Body Composition Analysis by Bioelectrical Impedance Vector Analysis in Patients With Hepatocellular Carcinoma Undergoing Chemoembolization.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Changes in body composition [ Time Frame: 1 hour before treatment, 2 weeks after treatment, and 1 month after treatment ] [ Designated as safety issue: No ]
    To evaluate any changes in corporal composition in patients undergoing chemoembolization.


Estimated Enrollment: 15
Study Start Date: April 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The patients will be recruited from the Radiology Department of a tertiary care center.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777698

Contacts
Contact: Aldo Torre, M.D., M.Sc. 54870900 ext 2711 detoal@yahoo.com
Contact: Astrid Ruiz-Margain, B.Sci 54870900 ext 2711 astridrm13@gmail.com

Locations
Mexico
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán" Recruiting
Mexico city, Mexico, 14000
Contact: Aldo Torre, M.D, M.Sc.    54870900 ext 2711    detoal@yahoo.com   
Principal Investigator: Aldo Torre, M.D., M.Sc.         
Sub-Investigator: Astrid Ruiz-Margain, B.Sci         
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
Study Chair: Aldo Torre, M.D, M.Sc. Instituto Nacional de Nutrición y Ciencias Médicas "Salvador Zubirán"
  More Information

No publications provided

Responsible Party: ALDO TORRE DELGADILLO, M.D., M.Sc., Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT01777698     History of Changes
Other Study ID Numbers: QMECR1
Study First Received: January 21, 2013
Last Updated: March 12, 2014
Health Authority: Mexico: Ethics Committee

Keywords provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
body composition
hepatocellular carcinoma
chemoembolization

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 July 29, 2014