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Completed

NCT Number: NCT02482259

Assessment of Frailty in Patients With Advanced Hepatocellular Cancers

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

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Key information

Conditions

Hepatocellular Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE7 7DN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. 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

  2. Time taken to complete assessments

    Time frame: Baseline, week 9 and week 18

    Time taken to completed assessments recorded by clinical trials officer

Secondary outcomes

  1. 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

  2. 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

Other outcomes

  1. Quality of Life - EORTC QCQ 30 and HCC18

    Time frame: Baseline, week 9 and week 18

  2. Biomarker assessment of frailty and associated factors

    Time frame: Baseline, week 9 and week 18

Sponsors and collaborators

Lead sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Other

Registry information

Acronym: FAC-L

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 26, 2015
Registry last updated
Sep 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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