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Clinical Trials/NCT02482259
NCT02482259
Completed
N/A

Assessment of Frailty in Patients With Advanced Hepatocellular Cancers

Newcastle-upon-Tyne Hospitals NHS Trust1 site in 1 country28 target enrollmentDecember 1, 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hepatocellular Cancer
Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Enrollment
28
Locations
1
Primary Endpoint
Percentage patients consenting for assessment out of number of patients approached
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2013
End Date
July 19, 2016
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

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

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

  • Frailty as a predictor of grade 3/4 toxicity(Baseline, week 9 and week 18)
  • Muscle mass and timed get up and go as predictors of outcome(Baseline, week 9 and week 18)

Study Sites (1)

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