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.
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.
Study population will be patients undergoing treatment for oesophageal cancer with curative intent that meet the above outlined inclusion and exclusion criteria.
Cohort
Prospective
Seismofit
Diagnostic testSeismofit® 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.
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.
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.
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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
Guy's and St Thomas' NHS Foundation Trust
Lead sponsor
University Hospital Southampton NHS Foundation Trust
Collaborator
Royal Marsden NHS Foundation Trust
Collaborator
Royal Surrey County Hospital NHS Foundation Trust
Collaborator
