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NCT Number: NCT06267378

Assessing Frailty and Its Impacts on Patients Facing Major GI 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.

Recruiting

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Key information

Conditions

Bowel Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

Doncaster, South Yorkshire, DN2 5LT, United Kingdom

Location status: Recruiting

Location contact

Doncaster Royal Infirmary

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Frailty measure

Other

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.

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

    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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

    as above

  2. Adverse events related to surgery assessed CTCAE classifications

    Time frame: 01/12/2029

    as above

  3. Tissue senescence correlation between baseline frailty and poor outcomes (including length of stay and adverse events)

    Time frame: 01/12/2029

    as above

  4. Digital mobility outcomes correlation with baseline frailty and poor outcomes (including length of stay and adverse events)

    Time frame: 01/12/2029

    as above

  5. Physical function assessment after surgery at 6 weeks, 3 months using the WHO DAS 2.0.

    Time frame: 01/12/2029

    as above

  6. Quality of life at 6 weeks, 3 months after surgery using the EQ-5D-5L

    Time frame: 01/12/2029

    as above

  7. Overall survival at 3 months and 5 years (the latter via cancer registry returns)

    Time frame: 01/12/2029

    as above

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Stoner

CONTACT

[email protected]

01302 644073

Jayan George

CONTACT

[email protected]

01302 366666

Sponsors and collaborators

Lead sponsor

Doncaster And Bassetlaw Hospitals NHS Foundation Trust

Other

Registry information

Official study title

Assessing Frailty and Its Impacts in Older Patients Facing Major Gastrointestinal Surgery

Important dates

Study start
2023
Primary completion
2024
Study completion
2029
First posted
Feb 20, 2024
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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