NCT05251922

Tolerance of Anti-Cancer Therapy in the Elderly

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: The Leeds Teaching Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Frailty
• Chemotherapeutic Toxicity

Timeline

• Start date: 2020-11-01
• Primary completion: 2023-01-01
• Completion: 2023-06-01
• First posted: 2022-02-23
• Last updated: 2022-02-23

Locations

1 site across 1 country: United Kingdom