NCT01744639

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 8, 2016

Status Verified

June 1, 2016

Enrollment Period

3 years

First QC Date

December 5, 2012

Last Update Submit

June 7, 2016

Conditions

Liver Carcinoma

Keywords

Hepatocellular carcinomaRadioablation

Outcome Measures

Primary Outcomes (1)

  • 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.

    Participants will be evaluated for a month

Secondary Outcomes (1)

  • Minimal hepatic encephalopathy

    Participants will be assessed for one month

Study Arms (1)

HCC under treatment with radioablation

EXPERIMENTAL

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

Interventions

HCC under treatment with radioablationBEHAVIORAL

The evaluation will take place over a period of 30 days.

Also known as: Anthropometry, Bioelectrical impedance
HCC under treatment with radioablation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • incomplete Applied Tests
  • disagreement of the person to perform any of the tests
  • monitoring Breach
  • Hospitalization or death after the first session radioablation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, D.f., 14000, Mexico

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

AnthropometryElectric Impedance

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesBiometryEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthElectric ConductivityElectricityElectromagnetic PhenomenaMagnetic PhenomenaPhysical Phenomena

Study Officials

  • Aldo Torre Delgadillo, M.D. M.Sc

    INCMNSZ

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigador Principal

Study Record Dates

First Submitted

December 5, 2012

First Posted

December 7, 2012

Study Start

December 1, 2012

Primary Completion

December 1, 2015

Study Completion

May 1, 2016

Last Updated

June 8, 2016

Record last verified: 2016-06

Locations

ME(1)