Clinical trial NCT05251922: Tolerance of Anti-Cancer Therapy in the Elderly
Official title: Tolerance of Anti-Cancer Therapy in the Elderly
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Frailty
Chemotherapeutic Toxicity
Keywords: frailty
chemotherapy tolerance
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults aged 65years or over, about to receive first line chemotherapy for a solid tumour based malignancy

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: To validate the CARG scoring system
timeFrame: 6 months follow up
Secondary outcomes:
measure: Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy - demographics
timeFrame: 6 months follow up
measure: Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy - tumour type
timeFrame: 6 months follow up
measure: Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy - chemotherapy type
timeFrame: 6 months follow up
measure: Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy - laboratory test results (Hb)
timeFrame: 6 months follow up
measure: Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy - laboratory test results (CrCl)
timeFrame: 6 months follow up
measure: 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)
timeFrame: 6 months follow up
measure: Describe frailty in elderly patients (>65years) in the UK NHS prior to starting chemotherapy using the Rockwood Clinical Frailty Score (CFS)
timeFrame: 6 months follow up
measure: Evaluate the predictive value of commonly used geriatric assessment tools in predicting chemotherapy tolerance
timeFrame: 6 months follow up
measure: The CARG score which reports the risk of grade 3-5 toxicity as assessed using CTCAEv5 as a percentage.
timeFrame: 6 months follow up
measure: Explore patients perception of risk associated with chemotherapy in this population
timeFrame: 6 months follow up
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds NHS Teaching Hospitals
Study officials:
affiliation: helen.dearden1@nhs.net
name: Helen C Dearden
role: PRINCIPAL_INVESTIGATOR
References: