Assessment of Frailty in Elderly Patients With Advanced Cancers

Terminated

• Conditions: Cancer

• Registration Number: NCT02482285
• Lead Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust

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.

Study Timeline

• Study Start: 2014-06-04
• Study First Submitted: 2015-06-12
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-26
• Primary Completion: 2016-01-25
• Study Completion: 2016-01-25
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-17
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage patients consenting for assessments out of number approached	Baseline	Number of patients consenting for the study as a percentage of number of patients approached about the study.
Time taken to complete assessments	Baseline, week 12 and week 24	Length of time participants take to complete study assessments

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Newcastle upon Tyne NHS Trust; 🇬🇧 Newcastle upon Tyne, United Kingdom