Frailty Clinical Trial - Tolerance of Anti-Cancer Therapy in the Elderly

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05251922
Study type	Observational
Source	The Leeds Teaching Hospitals NHS Trust
Contact	Helen C Dearden
Phone	01132433144
Email	helen.dearden1@nhs.net
Status	Recruiting
Phase
Start date	November 1, 2020
Completion date	June 1, 2023

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Tolerance of Anti-Cancer Therapy in the Elderly — TOASTIE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms