Frailty Clinical Trial
— TOASTIEOfficial title:
Tolerance of Anti-Cancer Therapy in the Elderly
NCT number | NCT05251922 |
Other study ID # | MO19/127559 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2020 |
Est. completion date | June 1, 2023 |
This is a multicentre observational study evaluating frailty and tolerance of chemotherapy in the elderly.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | June 1, 2023 |
Est. primary completion date | January 1, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Leeds NHS Teaching Hospitals | Leeds |
Lead Sponsor | Collaborator |
---|---|
The Leeds Teaching Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
6 months follow up | |
Secondary | Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy - demographics | The investigators are reporting demographics: age (years) and gender | 6 months follow up | |
Secondary | 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. | 6 months follow up | |
Secondary | Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy - chemotherapy type | The investigators will be reporting chemotherapy drugs delivered | 6 months follow up | |
Secondary | 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) |
6 months follow up | |
Secondary | 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) |
6 months follow up | |
Secondary | 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 | 6 months follow up | |
Secondary | 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 | 6 months follow up | |
Secondary | 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. |
6 months follow up | |
Secondary | The CARG score which reports the risk of grade 3-5 toxicity as assessed using CTCAEv5 as a percentage. | 6 months follow up | ||
Secondary | 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 |
6 months follow up |
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