Assessing Frailty and Its Impacts on Patients Facing Major GI Surgery

Recruiting

• Conditions: Bowel Cancer

• Registration Number: NCT06267378
• Lead Sponsor: Doncaster And Bassetlaw Hospitals NHS Foundation Trust

Brief Summary

The study team will look at 3 new tests that will make it easier to measure frailty in patients awaiting surgery for cancer and compare them against standard clinical measures of frailty in a pilot study. The expected outcome is that evidence will be collated in order to apply for a major grant to look at improving the care of frail patients with cancer in the future.

Detailed Description

Over 40% of patients with bowel cancer are over the age of 75. In older patients, rates of ill health and frailty are high, with frailty found in 6 in 10 patients over the age of 90. Surgery is the main treatment for bowel cancer, but the risks of surgery are higher in older people especially if they are frail. The main features of frailty are weight loss, lack of energy, weakness, slow walking speed and low activity levels. Frailty is a condition linked to an increased risk of death and major complications after surgery. As a result, older and frailer patients are often refused surgery for their cancer. If we could identify frailty more reliably before surgery, we could offer patients better counselling about the surgical risks and benefits. We could also offer treatments that might improve their fitness, making the surgery safer (pre-operative exercise, better post-operative support). Surgeons are not very good at measuring frailty because the clinical tests for it are complicated and take a long time to complete.

Study Timeline

• Study Start: 2023-08-30
• Status Verified: 2023-10
• Study First Submitted: 2023-10-24
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-20
• Last Update Submitted: 2024-07-05
• Last Update Posted: 2024-07-08
• Primary Completion: 2024-12-01
• Study Completion: 2029-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Male or female.
2. Aged 70 years and over.
3. Patients with a diagnosis of primary operable colorectal cancer where treatment includes a planned curative surgical procedure.
4. About to undergo elective surgery for cancer.
5. Mental capacity to consent.

Exclusion Criteria

1. Patients with unresectable cancer.
2. Patients presenting as an emergency.
3. Patients who are having chemotherapy or radiotherapy before their surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The sensitivity & specificity of tissue senescence for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events	01/12/2029	A further potential measure of frailty is tissue levels of senescence. Senescent cells are rare in the tissues of young organisms but become more common as tissues age, especially in adipose tissue, muscle and skin (Tchkonia et al., 2010). Both ageing and frailty are associated with cellular senescence, a mechanism of irreversible cell cycle arrest caused by persistent stress and damage, which contributes to the process of ageing, frailty and a range of diseases (Xu et al., 2018; Hickson et al., 2019). Senescent cells are causal to a wide range of diseases such as arthritis, arteriosclerosis and dementia and are also linked to the development of frailty in animal models.
The sensitivity & specificity of digital motion data for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events	01/12/2029	The development of biochemical assessments of frailty could also provide valuable information to guide the treatment of the older patient although there are very few that have been validated for clinical use across a range of settings.
The sensitivity & specificity of blood based biomarkers for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events	01/12/2029	A simple, validated biomarker of frailty, capable of identification of patients who are at an increased risk of adverse outcomes from surgery, would be of great value in the surgical decision-making process.

Secondary Outcome Measures

Name	Time	Method
Tissue senescence correlation between baseline frailty and poor outcomes (including length of stay and adverse events)	01/12/2029	as above
Blood biomarker correlation (baseline and post operative) with baseline frailty and poor outcomes (including length of stay and adverse events)	01/12/2029	as above
Overall survival at 3 months and 5 years (the latter via cancer registry returns)	01/12/2029	as above
Adverse events related to surgery assessed CTCAE classifications	01/12/2029	as above
Physical function assessment after surgery at 6 weeks, 3 months using the WHO DAS 2.0.	01/12/2029	as above
Quality of life at 6 weeks, 3 months after surgery using the EQ-5D-5L	01/12/2029	as above
Digital mobility outcomes correlation with baseline frailty and poor outcomes (including length of stay and adverse events)	01/12/2029	as above

Trial Locations

Locations (1)

Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust; 🇬🇧 Doncaster, South Yorkshire, United Kingdom