Assessing the Accuracy of Seismofit® as an Estimate of VO2 Peak in Patients With Hepato-pancreato-biliary, Colorectal, and Gastro-oesophageal Cancer

Recruiting

• Conditions: Pancreatic Cancer; Colorectal Cancer; Hepato-Biliary Carcinoma in Situ Nos; Oesophageal Cancer; Gastric Cancer

• Registration Number: NCT05831488
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

Our study aims to assess the relationship between the Seismofit® derived VO2 peak estimate and CPET-measured VO2 peak in patients who are having CPET as part of their preoperative workup. Our aim is to establish whether Seismofit® can be considered a cheaper, less resource intensive and better tolerated alternative to the CPET, or whether it might be useful as a screening tool to efficiently identify patients with exercise intolerance who may benefit from further characterisation by CPET.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-17
• Study Start: 2023-03-01
• Study First Submitted QC: 2023-04-24
• Last Update Submitted: 2023-04-24
• Study First Posted: 2023-04-26
• Last Update Posted: 2023-04-26
• Primary Completion: 2023-10-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Age ≥18
2. Scheduled for elective surgery for resection of HPB, colorectal or gastro-oesophageal primary or secondary cancer
3. Undergoing CPET as part of routine pre-operative investigations

Exclusion Criteria

1. Subjects unable to give voluntary written informed consent to participate in this study
2. Diagnosis of moderate or worse stenosis or regurgitation of any cardiac valve
3. Previous aortic or mitral valve surgery, valvuloplasty or transcatheter valve implantation
4. Permanent pacemaker or cardiac resynchronisation device in situ
5. Diagnosis of severe pulmonary hypertension
6. Permanent atrial fibrillation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the relationship between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak in HPB, gastro-oesophageal or colorectal cancer patients undergoing preoperative assessment for major surgery.	End of Trial (9 months)	Strength and direction of relationship (Pearson correlation coefficient) between Seismofit® -estimated VO2 peak and CPET-measured VO2 peak.

Secondary Outcome Measures

Name	Time	Method
Assess the relationship between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak in each surgical subgroup: HPB, gastro-oesophageal and colorectal cancer patients.	End of Trial (9 months)	Strength and direction of relationship (Pearson correlation coefficient) between Seismofit® -estimated VO2 peak and CPET-measured VO2 peak, as well as limits of agreement and bias (Bland-Altman analysis) in each surgical subgroup: HPB, gastro-oesophageal and colorectal cancer patients.
Assess limits of agreement and bias between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak	End of Trial (9 months)	Limits of agreement and bias between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak (Bland-Alman analysis)
Assess patient experience of the Seismofit® test using a brief measure that has been used previously in CPET research	End of Trial (9 months)	Patient concern, comfort, and overall satisfaction of Seismofit® measurement compared with CPET.
Assess the relationship between Seismofit® -estimated VO2 peak and other CPET derived variables: o Anaerobic Threshold (AT) o Peak Power Output (PPO) o Ventilatory equivalents for carbon dioxide (VE/VCO2)	End of Trial (9 months)	Strength and direction of relationship (Pearson correlation coefficient) between Seismofit® -estimated VO2 peak and the CPET-measured variables of AT, PPO and VE/VCO2

Trial Locations

Locations (1)

The Royal Marsden NHS Foundation Trust; 🇬🇧 London, United Kingdom