FrailtyTOASTIENCT05251922
Tolerance of Anti-Cancer Therapy in the Elderly
An observational study of Frailty and Chemotherapeutic Toxicity, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This is a multicentre observational study evaluating frailty and tolerance of chemotherapy in the elderly. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Chemotherapeutic Toxicity
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2020to 1 Jun 2023
- 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 65 years and older
- All sexes
- Older adult
Study population: Adults aged 65years or over, about to receive first line chemotherapy for a solid tumour based malignancy
Who may be able to join
- Age >65years
- About to start first line chemotherapy for a solid tumour based malignancy
- Chemotherapy given for any intent eg. adjuvant or palliative
- Estimated survival of >3months
- Able to comprehend and complete questionnaire.
Who cannot join
- Medical or psychiatric condition impairing ability to consent
- Participant is enrolled in another clinical trial
- Prior chemotherapy for any indication
- Receiving concurrent radiotherapy (RT) or immunotherapy (IT)
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds NHS Teaching Hospitals
Leeds
Helen C Dearden, 01132433144, helen.dearden1@nhs.net
Anne Gowing, 01132433144, Anne.gowing@nhs.net
About this study
This is a multicentre observational study evaluating frailty and tolerance of chemotherapy in the elderly.
Read the detailed description
This is a multicentre observational study evaluating frailty and tolerance of chemotherapy in the elderly.
The number of people with cancer over the age of 65 years is increasing and more older patients are being treated with chemotherapy. Previous research has shown that patients living with frailty are more likely to experience significant toxicity from chemotherapy.
A scoring system exists, the CARG (Cancer Aging Research Group) score), which using sociodemographics, tumour/treatment variables, laboratory test results (haemoglobin and creatinine clearance), geriatric assessment variables (function, co-morbidity, cognition, psychological state, social activity/support and nutritional status) predicts the likelihood of patients in this population developing a grade 3-5 toxicity. The CARG score ranges from 0 (lowest toxicity risk) to 19 (highest toxicity risk).
This scoring system was developed and validated in the USA (United States of America). It was not however found to be predictive of toxicity in Australia. To date it has not been evaluated, nor is used in routine practice in oncology in the UK (United Kingdom).
This study is looking at markers of frailty in patients >65years. The investigators seek to predict those who are at a higher risk of side effects from chemotherapy. The investigators are looking to validate the CARG score in a UK NHS (National Health Service) population and show feasibility of using this in routine practice. The investigators are also evaluating if other scoring systems which are routinely used to assess frailty (but have never been assessed for predicting toxicity) are useful in predicting toxicity.
Secondary objectives include describing frailty in this population, exploring patients' perceptions of risk associated with chemotherapy and demonstrating the added value of risk prediction tools compared to clinicians estimates of toxicity risk.
- Conditions
- Frailty, Chemotherapeutic Toxicity
- Keywords
- frailty, chemotherapy tolerance
- Medical subject headings
- Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the CARG scoring system
To validate the CARG scoring system (a score which is calculated by the doctor using patient information) in a UK real-world population and show feasibility of implementing CARG scoring in routine NHS practice.
The investigators will collect the information required and calculate a CARG score for each participant.
The investigators will record Grade 3-5 chemotherapy toxicities (as assessed using CTCAEv5) for each participant.
The investigators will evaluate if the CARG score is predictive of Grade 3-5 toxicity (as assessed using CTCAEv5) in this UK real-world population.
The investigators will record how long it takes to collect this information and calculate the score to see if it is feasible to implement this in a real world setting.
Measured: 6 months follow up
Secondary outcomes (10)
Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy - demographics
The investigators are reporting demographics: age (years) and gender
Measured: 6 months follow up
Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy - tumour type
The investigators are reporting tumour type eg. breast cancer, gastric cancer etc.
Measured: 6 months follow up
Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy - chemotherapy type
The investigators will be reporting chemotherapy drugs delivered
Measured: 6 months follow up
Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy - laboratory test results (Hb)
The investigators will be reporting laboratory test results prior to first cycle of chemotherapy
-haemoglobin (g/L)
Measured: 6 months follow up
Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy - laboratory test results (CrCl)
The investigators will be reporting laboratory test results prior to first cycle of chemotherapy
-creatinine clearance (mL/min)
Measured: 6 months follow up
Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy using SIOG (International Society of Geriatric Oncology) Geriatric Screening Tool (G8)
Investigators will calculate the SIOG (International Society of Geriatric Oncology) Geriatric Screening Tool (G8) and report the score
Measured: 6 months follow up
Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy using the Rockwood Clinical Frailty Score (CFS)
Investigators will record the Rockwood Clinical Frailty Score (CFS) and report the scores
Measured: 6 months follow up
Evaluate the predictive value of commonly used geriatric assessment tools in predicting chemotherapy tolerance
Frailty scoring systems (G8 and CFS) will be calculated. Grade 3-5 chemotherapy toxicities will (as assessed using CTCAEv5) will be recorded.
The investigators will assess if these scoring systems have utility in predicting risk of grade 3-5 chemotherapy toxicity.
Measured: 6 months follow up
The CARG score which reports the risk of grade 3-5 toxicity as assessed using CTCAEv5 as a percentage.
Measured: 6 months follow up
Explore patients perception of risk associated with chemotherapy in this population
Participants will report their perception of likelihood of developing a side effect from chemotherapy which would cause the participant to stay in hospital for one night or longer or have to stop treatment using the following options: Unlikely, Not very likely, Quite likely or Very likely, as well as using a percentage scale as seen below.
0 means I think it definitely won't happen to me → 100 means I think I will definitely need to stop treatment or stay hospital at some point during my treatment
0-----10-----20-----30-----40-----50-----60-----70-----80-----90----100
Measured: 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Nov 2020
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helen C Dearden, Principal investigator, helen.dearden1@nhs.net
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251922
- Sponsor's protocol ID
- MO19/127559
- Acronym
- TOASTIE
- Status last verified
- Feb 2022
- First submitted
- 26 Jan 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of Anti-Cancer Therapy in the Elderly
- ClinicalTrials.gov ID
- NCT05251922
- Acronym / sponsor ID
- TOASTIE / MO19/127559
- Conditions
- Frailty, Chemotherapeutic Toxicity
- Keywords
- frailty, chemotherapy tolerance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 23 Feb 2022 (actual)
- 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 is a multicentre observational study evaluating frailty and tolerance of chemotherapy in the elderly.
Detailed description
This is a multicentre observational study evaluating frailty and tolerance of chemotherapy in the elderly.
The number of people with cancer over the age of 65 years is increasing and more older patients are being treated with chemotherapy. Previous research has shown that patients living with frailty are more likely to experience significant toxicity from chemotherapy.
A scoring system exists, the CARG (Cancer Aging Research Group) score), which using sociodemographics, tumour/treatment variables, laboratory test results (haemoglobin and creatinine clearance), geriatric assessment variables (function, co-morbidity, cognition, psychological state, social activity/support and nutritional status) predicts the likelihood of patients in this population developing a grade 3-5 toxicity. The CARG score ranges from 0 (lowest toxicity risk) to 19 (highest toxicity risk).
This scoring system was developed and validated in the USA (United States of America). It was not however found to be predictive of toxicity in Australia. To date it has not been evaluated, nor is used in routine practice in oncology in the UK (United Kingdom).
This study is looking at markers of frailty in patients >65years. The investigators seek to predict those who are at a higher risk of side effects from chemotherapy. The investigators are looking to validate the CARG score in a UK NHS (National Health Service) population and show feasibility of using this in routine practice. The investigators are also evaluating if other scoring systems which are routinely used to assess frailty (but have never been assessed for predicting toxicity) are useful in predicting toxicity.
Secondary objectives include describing frailty in this population, exploring patients' perceptions of risk associated with chemotherapy and demonstrating the added value of risk prediction tools compared to clinicians estimates of toxicity risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Adults aged 65years or over, about to receive first line chemotherapy for a solid tumour based malignancy
Key inclusion criteria (5 listed)
- Age >65years
- About to start first line chemotherapy for a solid tumour based malignancy
- Chemotherapy given for any intent eg. adjuvant or palliative
- Estimated survival of >3months
- Able to comprehend and complete questionnaire.
Key exclusion criteria (5 listed)
- Medical or psychiatric condition impairing ability to consent
- Participant is enrolled in another clinical trial
- Prior chemotherapy for any indication
- Receiving concurrent radiotherapy (RT) or immunotherapy (IT)
- Unable to provide informed consent
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
To validate the CARG scoring system
Time frame: 6 months follow up
To validate the CARG scoring system (a score which is calculated by the doctor using patient information) in a UK real-world population and show feasibility of implementing CARG scoring in routine NHS practice. The investigators will collect the information required and calculate a CARG score for each participant. The investigators will record Grade 3-5 chemotherapy toxicities (as assessed using CTCAEv5) for each participant. The investigators will evaluate if the CARG score is predictive of Grade 3-5 toxicity (as assessed using CTCAEv5) in this UK real-world population. The investigators will record how long it takes to collect this information and calculate the score to see if it is feasible to implement this in a real world setting.
10 secondary outcomes
Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy - demographics
Time frame: 6 months follow up
Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy - tumour type
Time frame: 6 months follow up
Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy - chemotherapy type
Time frame: 6 months follow up
Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy - laboratory test results (Hb)
Time frame: 6 months follow up
Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy - laboratory test results (CrCl)
Time frame: 6 months follow up
Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy using SIOG (International Society of Geriatric Oncology) Geriatric Screening Tool (G8)
Time frame: 6 months follow up
Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy using the Rockwood Clinical Frailty Score (CFS)
Time frame: 6 months follow up
Evaluate the predictive value of commonly used geriatric assessment tools in predicting chemotherapy tolerance
Time frame: 6 months follow up
The CARG score which reports the risk of grade 3-5 toxicity as assessed using CTCAEv5 as a percentage.
Time frame: 6 months follow up
Explore patients perception of risk associated with chemotherapy in this population
Time frame: 6 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Helen C Dearden principal investigator
helen.dearden1@nhs.net
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 Frailty and Chemotherapeutic Toxicity, run by The Leeds Teaching 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 5 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: status not confirmed, as of the sponsor's last update on 23 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helen C Dearden (01132433144, helen.dearden1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate the CARG scoring system (time frame: 6 months follow up). 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 23 Feb 2022.