Bowel CancerNCT06267378
Assessing Frailty and Its Impacts on Patients Facing Major GI Surgery
An observational study of Bowel Cancer, run by Doncaster And Bassetlaw Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Cancer
- What is being tested?
- Frailty measure
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Aug 2023to 1 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Gastrointestinal cancer patients
Who may be able to join
- 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.
- Mental capacity to consent.
Who cannot join
- Patients with unresectable cancer.
- Patients presenting as an emergency.
- Patients who are having chemotherapy or radiotherapy before their surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster, South Yorkshire, DN2 5LT
Doncaster Royal Infirmary, dbth.clinicalresearch@nhs.net
About this study
Official title: Assessing Frailty and Its Impacts in Older Patients Facing Major Gastrointestinal Surgery
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.
Read the 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.
- Conditions
- Bowel Cancer
- Being tested
- Frailty measure
- Medical subject headings
- Intestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty measureOther
All 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 01/12/2029
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.
Measured: 01/12/2029
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.
Measured: 01/12/2029
Secondary outcomes (7)
Blood biomarker correlation (baseline and post operative) with baseline frailty and poor outcomes (including length of stay and adverse events)
as above
Measured: 01/12/2029
Adverse events related to surgery assessed CTCAE classifications
as above
Measured: 01/12/2029
Tissue senescence correlation between baseline frailty and poor outcomes (including length of stay and adverse events)
as above
Measured: 01/12/2029
Digital mobility outcomes correlation with baseline frailty and poor outcomes (including length of stay and adverse events)
as above
Measured: 01/12/2029
Physical function assessment after surgery at 6 weeks, 3 months using the WHO DAS 2.0.
as above
Measured: 01/12/2029
Quality of life at 6 weeks, 3 months after surgery using the EQ-5D-5L
as above
Measured: 01/12/2029
Overall survival at 3 months and 5 years (the latter via cancer registry returns)
as above
Measured: 01/12/2029
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start30 Aug 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Doncaster And Bassetlaw Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jayan George, Principal investigator, Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267378
- Sponsor's protocol ID
- 1174/2022/NCTS
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: TBC
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Frailty and Its Impacts in Older Patients Facing Major Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT06267378
- Acronym / sponsor ID
- 1174/2022/NCTS
- Conditions
- Bowel Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Doncaster And Bassetlaw Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gastrointestinal cancer patients
Key inclusion criteria (5 listed)
- 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.
- Mental capacity to consent.
Key exclusion criteria (3 listed)
- Patients with unresectable cancer.
- Patients presenting as an emergency.
- Patients who are having chemotherapy or radiotherapy before their surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frailty measureAll 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. | Other | – |
Primary outcome
The sensitivity & specificity of digital motion data for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events
Time frame: 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 tissue senescence for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events
Time frame: 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 blood based biomarkers for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events
Time frame: 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.
7 secondary outcomes
Blood biomarker correlation (baseline and post operative) with baseline frailty and poor outcomes (including length of stay and adverse events)
Time frame: 01/12/2029
Adverse events related to surgery assessed CTCAE classifications
Time frame: 01/12/2029
Tissue senescence correlation between baseline frailty and poor outcomes (including length of stay and adverse events)
Time frame: 01/12/2029
Digital mobility outcomes correlation with baseline frailty and poor outcomes (including length of stay and adverse events)
Time frame: 01/12/2029
Physical function assessment after surgery at 6 weeks, 3 months using the WHO DAS 2.0.
Time frame: 01/12/2029
Quality of life at 6 weeks, 3 months after surgery using the EQ-5D-5L
Time frame: 01/12/2029
Overall survival at 3 months and 5 years (the latter via cancer registry returns)
Time frame: 01/12/2029
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: Undecided. TBC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jayan George principal investigator
Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Cancer, run by Doncaster And Bassetlaw Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jayan George (01302 366666, jayan.george@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity & specificity of digital motion data for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events (time frame: 01/12/2029). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.