Evaluation of Seismocardiography(SCG) for Assessing Fitness and Predicting Outcomes in Oesophageal Cancer Surgery

NCT07159711 | Not Yet Recruiting

• 1 other identifier: 342434
• Study Type: observational
• Target: 164
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oesophageal Cancer; Oesophageal Adenocarcinoma; Prehabilitation; Oesophagectomy; Neoadjuvant Chemotherapy

Keywords

oesophageal cancer; Oesophagectomy; Fitness; Prehabilitation; Neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  2 Years

Secondary Outcomes (5)

• Seismofit® estimated VO2Peak reading accuracy compared to "gold standard" CPET measured VO2Peak.

  2 Years

• To compare if Seismofit® is able to stratify patients into the lower quartiles of fitness accurately based on CPET measured fitness.

  2 Years

• To investigate Seismofit® estimated fitness and Chemotherapy compliance & tolerability.

  2 Years

• ITU length of stay (and re-admission)

  2 Years

• Anastomotic leak rates

  2 Years

Interventions

Seismofit DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will be patients undergoing treatment for oesophageal cancer with curative intent that meet the above outlined inclusion and exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• University Hospital Southampton NHS Foundation Trust: collaborator
• Royal Marsden NHS Foundation Trust: collaborator
• Royal Surrey County Hospital NHS Foundation Trust: collaborator

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Andrew Davies, MD FRCS

  Guy's and St Thomas NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kesav Aditya Vijayagopal, DMS

CONTACT

+447706649746; kesav.vijayagopal1@nhs.net

Andrew Davies, MD FRCS

CONTACT

ardavies22@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: September 8, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• 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.