Assessment of Frailty in Patients With Advanced Hepatocellular Cancers

Completed

• Conditions: Hepatocellular Cancer

• Registration Number: NCT02482259
• Lead Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust

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.

Study Timeline

• Study Start: 2013-12-01
• Study First Submitted: 2015-06-12
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-26
• Primary Completion: 2016-07-19
• Study Completion: 2016-07-19
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-14
• Last Update Posted: 2017-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Newcastle upon Tyne Hospitals NHS Foundation Trust; 🇬🇧 Newcastle upon Tyne, United Kingdom