An observational study in Oesophageal Cancer, Oesophageal Adenocarcinoma and Prehabilitation, sponsored by Guy's and St Thomas' NHS Foundation Trust. Recruiting at 4 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Guy's and St Thomas' NHS Foundation Trust · Observational
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.
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.
1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.
This study's planned enrollment of 164 is below the median of 200 across 432 observational studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 295 studies on the registry; 80 are open to participants now.
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Study population will be patients undergoing treatment for oesophageal cancer with curative intent that meet the above outlined inclusion and exclusion criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Seismofit® is a 3 x 5 x 1.5 cm Class I medical device manufactured by Ventriject, which utilizes SCG principles and machine learning to estimate an individual's fitness. It is afixed to a patient's sternum with an adhesive patch. It measures the amplitude and timing of vibrations on the chest using accelerometers. The device then averages the data collected over 45 seconds to create the SCG. From the SCG, several maxima and minima (fiducial points) are identified, which correlate to the opening and closing of the mitral and aortic valves. Features of the SCG, including the timing, frequency, amplitude, and variability of these points, are then incorporated into an algorithm that also considers patient height, weight, age, and sex to calculate the VO2 peak. Data is transmitted via Bluetooth to an allocated smartphone app.
Also known as: Seismocardiography based VO2 Max Estimation of Fitness
Rate of pneumonia as defined by the Esophageal Complications Consensus Group criteria (ECCG).
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.
Time frame: 2 Years
Overall rate of complications as defined by the Clavien-Dindo classification
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.
Time frame: 2 Years
Total hospital length of stay for patients being treated for Oesophageal cancer
This study will evaluate whether fitness and changes in the Seismofit estimated VO2Max will be able to predict increased hospital length of stay.
Time frame: 2 Years
Seismofit® estimated VO2Peak reading accuracy compared to "gold standard" CPET measured VO2Peak.
This study will evaluate the association between Seismofit® estimated VO2Peak to the gold standard CPET measured VO2Peak.
Time frame: 2 Years
To compare if Seismofit® is able to stratify patients into the lower quartiles of fitness accurately based on CPET measured fitness.
This study will evaluate whether Seismofit® is able to accurately stratify patients into the same quartiles of fitness as CPET.
Time frame: 2 Years
To investigate Seismofit® estimated fitness and Chemotherapy compliance & tolerability.
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.
Time frame: 2 Years
ITU length of stay (and re-admission)
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.
Time frame: 2 Years
Anastomotic leak rates
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.
Time frame: 2 Years
Not enrolling at this site.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All collected pseudonymised datapoints that underlie results in publication will be shared. The individual consent forms will be stored at each of the research sites. At the time of upload to the REDCap research database, a case reporting form code number will be generated. Patient identifiable information will not leave the research site at which the patient receives treatment.
Supporting information: Statistical analysis plan, Informed consent form, Clinical study report
Time frame: June 2025
Access criteria: Only local research teams will have access to patient-identifiable data. The central research team at GSTT will have access to pseudonymized data, except for patients recruited locally at GSTT. At the time of upload onto REDCap by the local research team, a case number will be used to pseudonymise patient data. This case number will be recorded on the consent form and may be used if research teams need to trace and link back to the patient. Consent forms will be stored in a secure NHS computer system folder at each local research site or, where paper forms are used, in a secure locker. In the event paper case reporting forms are used, they will also be stored similarly to the paper consent forms in a secure locker. In both electronic and physical cases, access to patient-identifiable documentation will be limited to the local PI/trial manager and other authorised personnel (research students, nursing staff, etc.) involved in the data set's collection, verification or analysis.
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