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Clinical Trials/NCT02482285
NCT02482285
Terminated
N/A

Assessment of Frailty in Elderly Patients With Advanced Cancers

Newcastle-upon-Tyne Hospitals NHS Trust1 site in 1 country8 target enrollmentJune 4, 2014
ConditionsCancer

Overview

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

Overview

Brief Summary

This study is looking at the feasibility of performing frailty assessments on elderly patients with advanced cancers

Detailed Description

This study is primarily looking to see if it is feasible to assess frailty in patients age 70 years and above with advanced cancers. it is also evaluating whether there may be any correlation between these assessments and toxicity and treatment and outcome. The assessments include: Frailty score, nutritional assessment, comorbidity score and quality of life. In addition sarcopenia will be assessed using timed walk, grip strength and muscle mass measurement from imaging performed as part of routine clinical care. The assessments will be performed at baseline, week 12 and week 24. There is the option for patients to also donate blood samples for research purposes.

Registry
clinicaltrials.gov
Start Date
June 4, 2014
End Date
January 25, 2016
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

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

Eligibility Criteria

Inclusion Criteria

  • Histological diagnosis of advanced carcinoma - not suitable for curative treatment
  • Age 70 years or over
  • seen by an oncologist for consideration of palliative systemic medical therapy and decision regarding management already made
  • WHO Performance Status 0-2
  • Written informed consent

Exclusion Criteria

  • Hepatocellular cancer
  • Prostate cancer
  • Breast cancer

Outcomes

Primary Outcomes

Percentage patients consenting for assessments out of number approached

Time Frame: Baseline

Number of patients consenting for the study as a percentage of number of patients approached about the study.

Time taken to complete assessments

Time Frame: Baseline, week 12 and week 24

Length of time participants take to complete study assessments

Secondary Outcomes

  • Sarcopenia as a predictor of outcome(baseline, week 12 and week 24)
  • Frailty as a predictor of grade 3/4 toxicity(baseline)
  • Quality of life EORTC QCQ 30(baseline, week 12 and week 24)
  • Biomarker assessment of frailty and associated factors which may include genetic analysis(baseline, week 12 and week 24)

Study Sites (1)

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