CancerFAC-CNCT02482285
Assessment of Frailty in Elderly Patients With Advanced Cancers
An observational study of Cancer, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study is looking at the feasibility of performing frailty assessments on elderly patients with advanced cancers Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cancer
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jun 2014to 25 Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with advanced cancers
Who may be able to join
- 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
Who cannot join
- Hepatocellular cancer
- Prostate cancer
- Breast cancer
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Newcastle upon Tyne NHS Trust
Newcastle upon Tyne, NE7 7DN
About this study
This study is looking at the feasibility of performing frailty assessments on elderly patients with advanced cancers
Read the 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.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Time taken to complete assessments
Length of time participants take to complete study assessments
Measured: Baseline, week 12 and week 24
Secondary outcomes (4)
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
Measured: baseline
Sarcopenia as a predictor of outcome
sarcopenia at baseline and over time as a predictor of outcome
Measured: baseline, week 12 and week 24
Quality of life EORTC QCQ 30
Participants complete EORTC QCQ 30 questionnaire
Measured: baseline, week 12 and week 24
Biomarker assessment of frailty and associated factors which may include genetic analysis
Assessment of frailty biomarkers in blood samples
Measured: baseline, week 12 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study start4 Jun 2014
- Primary completion25 Jan 2016
- Study completion25 Jan 2016
Why it stopped: Difficulty recruiting. Study aims now overlap standard of care assessments and future planned studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alastair Greystoke, MRCP, PhD, MBChB, MSc, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482285
- Sponsor's protocol ID
- 6731
- Acronym
- FAC-C
- Status last verified
- Oct 2022
- First submitted
- 12 Jun 2015
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Frailty in Elderly Patients With Advanced Cancers
- ClinicalTrials.gov ID
- NCT02482285
- Acronym / sponsor ID
- FAC-C / 6731
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting. Study aims now overlap standard of care assessments and future planned studies.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Study start
- 4 Jun 2014 (actual)
- Primary completion
- 25 Jan 2016 (actual)
- Study completion
- 25 Jan 2016 (actual)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with advanced cancers
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Hepatocellular cancer
- Prostate cancer
- Breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Frailty as a predictor of grade 3/4 toxicity
Time frame: baseline
Sarcopenia as a predictor of outcome
Time frame: baseline, week 12 and week 24
Quality of life EORTC QCQ 30
Time frame: baseline, week 12 and week 24
Biomarker assessment of frailty and associated factors which may include genetic analysis
Time frame: baseline, week 12 and week 24
Results and safety
The study was stopped early (reason given: Difficulty recruiting. Study aims now overlap standard of care assessments and future planned studies.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alastair Greystoke, MRCP, PhD, MBChB, MSc principal investigator
Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty recruiting. Study aims now overlap standard of care assessments and future planned studies.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage patients consenting for assessments out of number approached (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.