Assessment of Frailty in Elderly Patients With Advanced Cancers

Cancer Clinical Trial

— FAC-C  

Official title:

Assessment of Frailty in Elderly Patients With Advanced Cancers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02482285
• Other study ID #: 6731
• Status: Terminated
• Start date: June 4, 2014
• Est. completion date: January 25, 2016

Study information

• Verified date: October 2022
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: January 25, 2016
• Est. primary completion date: January 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Frailty

Locations

Country	Name	City	State
United Kingdom	Newcastle upon Tyne NHS Trust	Newcastle upon Tyne

Sponsors (1)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage patients consenting for assessments out of number approached	Number of patients consenting for the study as a percentage of number of patients approached about the study.	Baseline
Primary	Time taken to complete assessments	Length of time participants take to complete study assessments	Baseline, week 12 and week 24
Secondary	Frailty as a predictor of grade 3/4 toxicity	Evaluate whether there is a possible correlation between frailty score at baseline and development of grade 3/4 toxicity during anticancer treatment	baseline
Secondary	Sarcopenia as a predictor of outcome	sarcopenia at baseline and over time as a predictor of outcome	baseline, week 12 and week 24
Secondary	Quality of life EORTC QCQ 30	Participants complete EORTC QCQ 30 questionnaire	baseline, week 12 and week 24
Secondary	Biomarker assessment of frailty and associated factors which may include genetic analysis	Assessment of frailty biomarkers in blood samples	baseline, week 12 and week 24