Tolerance of Anti-Cancer Therapy in the Elderly (TOASTIE)

This is a multicentre observational study evaluating frailty and tolerance of chemotherapy in the elderly.

Study Overview

• Status: Recruiting
• Conditions: Frailty; Chemotherapeutic Toxicity

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Helen C Dearden; Phone Number: 01132433144; Email: helen.dearden1@nhs.net
• Study Contact Backup: Name: Anne Gowing; Phone Number: 01132433144; Email: Anne.gowing@nhs.net

Study Locations

• United Kingdom
  • Leeds, United Kingdom
    • Recruiting
    • Leeds NHS Teaching Hospitals
    • Contact: Helen C Dearden; Phone Number: 01132433144; Email: helen.dearden1@nhs.net
    • Contact: Anne Gowing; Phone Number: 01132433144; Email: Anne.gowing@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults aged 65years or over, about to receive first line chemotherapy for a solid tumour based malignancy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
The CARG score which reports the risk of grade 3-5 toxicity as assessed using CTCAEv5 as a percentage.		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	6 months follow up

Collaborators and Investigators

• Sponsor: The Leeds Teaching Hospitals NHS Trust
• Investigators: Principal Investigator: Helen C Dearden, helen.dearden1@nhs.net

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): February 23, 2022

Study Record Updates

• Last Update Posted (Actual): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 22, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: frailty; chemotherapy tolerance
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: MO19/127559

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No