Assessment of Frailty in Patients With Advanced Hepatocellular Cancers

Hepatocellular Cancer Clinical Trial

— FAC-L  

Official title:

Assessment of Frailty in Patients With Advanced Hepatocellular Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02482259
• Other study ID #: 6730
• Status: Completed
• Phase: N/A
• First received: June 12, 2015
• Last updated: September 14, 2017
• Start date: December 1, 2013
• Est. completion date: July 19, 2016

Study information

• Verified date: September 2017
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is looking at the feasibility of performing frailty assessments on patients with advanced hepatocellular cancer.

Description:

This study is primarily looking to see if it is feasible to assess frailty in patients with advanced hepatocellular cancer. It is also evaluating whether there may be any correlation between these assessments and toxicity of treatment and outcome.

The assessments include: Frailty score, nutritional assessment, comorbidity score and quality of life. In addition sarcopenia will be assessed measuring muscle mass from imaging performed as part of routine clinical care.

The assessments will be performed at baseline on entry into the study, at week 9 and week 18.

There is the option for patients to also donate a blood samples for research purposes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 19, 2016
• Est. primary completion date: July 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a diagnosis of hepatocellular cancer not suitable for curative treatment

• Seen by an oncologist or hepatologist for consideration of palliative treatment and a decision regarding management already made

• WHO Performance status 0-2

• Childs Pugh Score A or B

• Written informed consent

Exclusion Criteria:

Related Conditions & MeSH terms

• Hepatocellular Cancer
• Liver Neoplasms

Locations

Country	Name	City	State
United Kingdom	Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle upon Tyne

Sponsors (1)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life - EORTC QCQ 30 and HCC18		Baseline, week 9 and week 18
Other	Biomarker assessment of frailty and associated factors		Baseline, week 9 and week 18
Primary	Percentage patients consenting for assessment out of number of patients approached	Number of patients consenting for the study as a percentage of the number of patients approached about the study	baseline
Primary	Time taken to complete assessments	Time taken to completed assessments recorded by clinical trials officer	Baseline, week 9 and week 18
Secondary	Frailty as a predictor of grade 3/4 toxicity	Frailty score at baseline and during study time predict for outcome	Baseline, week 9 and week 18
Secondary	Muscle mass and timed get up and go as predictors of outcome	muscle mass as measured on routine CT scans and get up and go as measured in frailty score	Baseline, week 9 and week 18