Evaluation of Seismocardiography(SCG) for Assessing Fitness and Predicting Outcomes in Oesophageal Cancer Surgery
- Conditions
- Oesophageal CancerPrehabilitationOesophageal AdenocarcinomaOesophagectomyNeoadjuvant Chemotherapy
- Registration Number
- NCT07159711
- Lead Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Brief Summary
Oesophageal cancer is a common cause of cancer death worldwide. Curative treatment involves chemotherapy and surgery but has significant risks. Therefore, patient selection and improving physical fitness to withstand such major treatment is important to reduce the risk of complications. Physical fitness is traditionally measured by a specialised exercise test called Cardiopulmonary exercise testing (CPET), which can take up to one hour and requires specialised staff and expensive equipment such as a graded exercise bike or treadmill. Seismofit is a small device (smaller than a smartphone) used to estimate fitness in patients in under three minutes while lying down at rest. It measures the vibrations generated by the heart and, together with patient height, weight, age, and gender, accurately estimates fitness using an algorithm developed in healthy patients. The device has never been tested in a large group of oesophageal cancer patients to see if it can be used to predict complications in patients undergoing cancer treatment.
In this study, patients undergoing Oesophageal cancer treatment with chemotherapy or chemoradiotherapy and surgery will have Seismofit measurements at various points during their treatment to see if we can predict complications and hospital stay. Secondly, this study will also evaluate the accuracy of Seismofit compared to the gold standard CPET results in cancer patients.
- Detailed Description
Oesophageal cancer is the 8th most common cause of cancer and the 6th leading cause of cancer-related deaths worldwide(West et al., 2016; Liu et al., 2023). Surgery with curative intent has been associated with significant morbidity and mortality despite recent advancements in anaesthesia and surgical techniques(Wu et al., 2014). Good patient selection with optimisation of cardiorespiratory fitness (CRF) is essential to improve surgical outcomes(West et al., 2014; Ozova et al., 2022). This is particularly important given that most oesophageal cancer patients undergo neo-adjuvant treatment (e.g. chemotherapy), which is known to have a significant adverse effect on patient fitness before surgery (mean reduction of 12.1% in VO2Peak) (Jack et al., 2014). A lower baseline level of fitness has also been shown to be associated with morbidity and mortality in patients undergoing treatment with curative intent (Hennis et al., 2011; West et al., 2024). Prehabilitation is now considered the standard of care in oesophageal cancer surgery, with societal guidance recently recommending a baseline fitness assessment to tailor the intervention as well as a means of monitoring response (Walker et al., 2024).
Cardiopulmonary Exercise Testing (CPET) is considered the gold standard in measuring the CRF of an individual by obtaining the maximal volume of oxygen consumed (VO2Peak) in samples of expired gas during a graded effort cycle ergometer test (Krogh et al., 2020; Levett et al., 2018a). However, CPET is a resource-intensive, costly, time-consuming test (requiring up to 60 minutes) and creates a significant time burden on patients with already busy treatment schedules. In a UK survey of prehabilitation practice, 50% of Upper Gastrointestinal (UGI) units used CPET at baseline, with only 80% of these (40% total) using CPET for response assessment (Barman et al. 2024 in revision for publication Annals RCS Eng).
Seismofit® is a device that accurately estimates the VO2Peak using machine learning algorithms incorporating seismocardiography (SCG) and patient parameters such as height, weight, age, and gender. SCG is a process by which vibrations generated by the heart during its regular physiological cycles are characterised and mapped for changes in morphology, frequency, intensity and character(Sørensen et al., 2018). Key advantages of Seismofit® include its inter-test reliability, rapid availability of results (i.e., estimation of fitness in under 3 minutes in an outpatient setting), and accurate estimation of fitness in a resting patient (Hansen et al., 2023a). The accuracy of Seismofit® in comparison to CPET-measured CRF has previously been demonstrated with a Mean Absolute Percentage Error (MAPE) of 12.3% in healthy adult populations(Hansen et al., 2023b). However, there is minimal data on cancer patients, and no studies have correlated VO2Peak generated by Seismofit® to clinical outcomes.
Given the potential benefits of Seismofit® over CPET, this study will investigate its validity in a clinical setting across four major Oesophageal cancer resection centres (Guy's and St Thomas NHS Foundation Trust (GSTT), University Hospitals Southampton (UHS), Royal Marsden NHS Foundation Trust (RM) and Royal Surrey NHS Foundation Trust (RS).
This will be the first study to evaluate the use of Seismofit® in a large volume of oesophageal cancer patients. With correlation to clinical outcomes, this study will serve as the basis for future research into the use of Seismofit® in a clinical setting.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 164
- Age >=18
- Diagnosis of Oesophageal cancer (T0-4 N0-3 M0, Oesophageal / Gastro-Oesophageal Junction (GOJ) type 1-2 adenocarcinoma
- Patients being considered for curative treatment (i.e. due to undergo NAC and Oesophagectomy / Oesophago-Gastrectomy [open / MIO / hybrid / robotic])
- Patients able to give informed consent
- Pregnant patients.
- Patients under the age of 18.
- Patients undergoing primary Oesophagectomy +/- Oesophago-Gastrectomy with no neoadjuvant therapy.
- Patients undergoing Neoadjuvant chemoradiotherapy.
- Patient's being treated with curative intent for Oesophageal Squamous cell carcinoma
- Patients that are deemed not fit or suitable for Oesophagogastric cancer resection as part of a Multi-Disciplinary Team meeting decision.
- Patients with implanted devices such as pacemakers or cardioverter-defibrillators.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of pneumonia as defined by the Esophageal Complications Consensus Group criteria (ECCG). 2 Years This study will evaluate whether fitness and changes in the Seismofit estimated VO2Max through the treatment period will be able to predict increased rates of pneumonia.
Overall rate of complications as defined by the Clavien-Dindo classification 2 Years This study will evaluate whether fitness and changes in the Seismofit estimated VO2Max through the treatment period will be able to predict increased overall complications as well overall major complications defined as Clavien-Dindo Classification of III and above.
Total hospital length of stay for patients being treated for Oesophageal cancer 2 Years This study will evaluate whether fitness and changes in the Seismofit estimated VO2Max will be able to predict increased hospital length of stay.
- Secondary Outcome Measures
Name Time Method Seismofit® estimated VO2Peak reading accuracy compared to "gold standard" CPET measured VO2Peak. 2 Years This study will evaluate the association between Seismofit® estimated VO2Peak to the gold standard CPET measured VO2Peak.
To compare if Seismofit® is able to stratify patients into the lower quartiles of fitness accurately based on CPET measured fitness. 2 Years This study will evaluate whether Seismofit® is able to accurately stratify patients into the same quartiles of fitness as CPET.
To investigate Seismofit® estimated fitness and Chemotherapy compliance & tolerability. 2 Years This study will investigate whether patients with higher Seismofit estimated VO2Max will tolerate neoadjuvant chemotherapy better than those classified within the lower levels of fitness.
ITU length of stay (and re-admission) 2 Years This study will investigate whether patients with lower Seismofit estimated VO2Max, and more rapid decline in this fitness after Oesophagectomy will have longer lengths of stay in Intensive Treatment Units (ITU) or have higher return to ITU when they are stepped down to ward level care.
Anastomotic leak rates 2 Years This study will investigate whether patients with lower Seismofit estimated VO2Max, and more rapid decline in this fitness after Oesophagectomy will have higher anastomotic leak rates.