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Assessment of Frailty in Elderly Patients With Advanced Cancers

Assessment of Frailty in Elderly Patients With Advanced Cancers

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02482285
Acronym
FAC-C
Enrollment
8
Registered
2015-06-26
Start date
2014-06-04
Completion date
2016-01-25
Last updated
2022-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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.

Interventions

None listed

Sponsors

Newcastle-upon-Tyne Hospitals NHS Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage patients consenting for assessments out of number approachedBaselineNumber of patients consenting for the study as a percentage of number of patients approached about the study.
Time taken to complete assessmentsBaseline, week 12 and week 24Length of time participants take to complete study assessments

Secondary

MeasureTime frameDescription
Frailty as a predictor of grade 3/4 toxicitybaselineEvaluate whether there is a possible correlation between frailty score at baseline and development of grade 3/4 toxicity during anticancer treatment
Sarcopenia as a predictor of outcomebaseline, week 12 and week 24sarcopenia at baseline and over time as a predictor of outcome
Quality of life EORTC QCQ 30baseline, week 12 and week 24Participants complete EORTC QCQ 30 questionnaire
Biomarker assessment of frailty and associated factors which may include genetic analysisbaseline, week 12 and week 24Assessment of frailty biomarkers in blood samples

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026