Assessment of Frailty in Patients With Advanced Hepatocellular Cancers (FAC-L)

September 14, 2017 updated by: Newcastle-upon-Tyne Hospitals NHS Trust
This study is looking at the feasibility of performing frailty assessments on patients with advanced hepatocellular cancer.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Newcastle Upon Tyne Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Hepatocellular cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Investigators

  • Principal Investigator: Elizabeth R Plummer, MD, MRCP, BA, DPhil, Newcastle Unversity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

July 19, 2016

Study Completion (Actual)

July 19, 2016

Study Registration Dates

First Submitted

June 12, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimate)

June 26, 2015

Study Record Updates

Last Update Posted (Actual)

September 15, 2017

Last Update Submitted That Met QC Criteria

September 14, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6730

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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