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

Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust (Other)
Overall Status
Completed
CT.gov ID
NCT02482259
Collaborator
(none)
28
Enrollment
1
Location
31.6
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    28 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Frailty in Patients With Advanced Hepatocellular Cancers
    Actual Study Start Date :
    Dec 1, 2013
    Actual Primary Completion Date :
    Jul 19, 2016
    Actual Study Completion Date :
    Jul 19, 2016

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. Time taken to complete assessments [Baseline, week 9 and week 18]

      Time taken to completed assessments recorded by clinical trials officer

    Secondary Outcome Measures

    1. 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

    2. 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 Outcome Measures

    1. Quality of Life - EORTC QCQ 30 and HCC18 [Baseline, week 9 and week 18]

    2. Biomarker assessment of frailty and associated factors [Baseline, week 9 and week 18]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Newcastle upon Tyne Hospitals NHS Foundation Trust Newcastle upon Tyne United Kingdom NE7 7DN

    Sponsors and Collaborators

    • Newcastle-upon-Tyne Hospitals NHS Trust

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Newcastle-upon-Tyne Hospitals NHS Trust
    ClinicalTrials.gov Identifier:
    NCT02482259
    Other Study ID Numbers:
    • 6730
    First Posted:
    Jun 26, 2015
    Last Update Posted:
    Sep 15, 2017
    Last Verified:
    Sep 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Neoplasms
    Carcinoma, Hepatocellular
    Frailty

    Study Results

    No Results Posted as of Sep 15, 2017