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

The Leeds Teaching Hospitals NHS Trust

Status: Unknown

Conditions: Chemotherapeutic Toxicity; Frailty

Study type: Observational

Funder types: Other

Identifiers

NCT05251922

MO19/127559

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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