Assessment of Frailty in Patients With Advanced Hepatocellular Cancers

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02482259

Acronym

FAC-L

Enrollment

Registered

2015-06-26

Start date

2013-12-01

Completion date

2016-07-19

Last updated

2017-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Cancer

Brief summary

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

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

N/A \-

Design outcomes

Primary

Measure	Time frame	Description
Percentage patients consenting for assessment out of number of patients approached	baseline	Number of patients consenting for the study as a percentage of the number of patients approached about the study
Time taken to complete assessments	Baseline, week 9 and week 18	Time taken to completed assessments recorded by clinical trials officer

Secondary

Measure	Time frame	Description
Frailty as a predictor of grade 3/4 toxicity	Baseline, week 9 and week 18	Frailty score at baseline and during study time predict for outcome
Muscle mass and timed get up and go as predictors of outcome	Baseline, week 9 and week 18	muscle mass as measured on routine CT scans and get up and go as measured in frailty score

Other

Measure	Time frame
Quality of Life - EORTC QCQ 30 and HCC18	Baseline, week 9 and week 18
Biomarker assessment of frailty and associated factors	Baseline, week 9 and week 18

Countries

United Kingdom

Outcome results