Assessing Frailty and Its Impacts on Patients Facing Major GI Surgery
ConditionBowel Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDoncaster And Bassetlaw Hospitals NHS Foundation Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female.
Aged 70 years and over.
Patients with a diagnosis of primary operable colorectal cancer where treatment includes a planned curative surgical procedure.
About to undergo elective surgery for cancer.
Disqualifiers
Patients with unresectable cancer.
Patients presenting as an emergency.
Patients who are having chemotherapy or radiotherapy before their surgery.
Trial population
Gastrointestinal cancer patients
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Frailty measure
Other interventionAll participants will be asked to complete baseline assessments and a blood test. 30 participants out of the 100 will be selected to wear a digital motion device before their surgery for seven days. (15 participants will be non-frail and 15 patients will be frail). Where possible, all baseline assessments will be scheduled to coincide with a routine clinic/hospital visit. The first assessment will complete functional, frailty, nutritional, and quality of life questionnaires. A blood test will be taken for baseline tests and metabolomic assessment. Participants who opt into having a digital motion device will also be shown how to use the device and will wear this for seven days. Written instructions to fit the device will also be given.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
The sensitivity & specificity of digital motion data for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events
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.
Time frame
01/12/20292
The sensitivity & specificity of tissue senescence for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events
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.
Time frame
01/12/20293
The sensitivity & specificity of blood based biomarkers for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events
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.
Time frame
01/12/2029Secondary outcomes
1
Blood biomarker correlation (baseline and post operative) with baseline frailty and poor outcomes (including length of stay and adverse events)
as above
Time frame
01/12/20292
Adverse events related to surgery assessed CTCAE classifications
as above
Time frame
01/12/20293
Tissue senescence correlation between baseline frailty and poor outcomes (including length of stay and adverse events)
as above
Time frame
01/12/20294
Digital mobility outcomes correlation with baseline frailty and poor outcomes (including length of stay and adverse events)
as above
Time frame
01/12/2029Sponsors and contacts
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Source ClinicalTrials.gov