Clinical Trial Comparing Standard Care Versus Prehabilitation in Patients Undergoing Cancer Surgery (SPECS)

  • STATUS
    Recruiting
  • End date
    May 30, 2023
  • participants needed
    40
  • sponsor
    East Lancashire Hospitals NHS Trust
Updated on 9 August 2022
cancer surgery

Summary

To determine whether exercise and nutrition prehabilitation improves patient outcomes after cancer surgery

Description

Preliminary qualitative and quantitative studies suggest that there are benefits (reduced length of stay, improved cardiorespiratory function, reduced postoperative complications and improved quality of life) when prehabilitation is used with the context of cancer care. In 2017 Macmillian Cancer Support developed a strategic 'Evidence and Insight' review on prehabilitation. The outcome of this was to incorporate prehabilitation into routine cancer care and to develop principles and guidance for prehabilitation. This study aims to support this vision and answer some of the questions on the patients who are most likely to benefit from prehabilitation and to quantify some of these benefits by investigating the molecular processes that influence clinical changes

This study primarily seeks to assess the cardiovascular and biological impact of prehabilitation (exercise, nutrition) on patients undergoing hepatobiliary and colorectal cancer surgery. The investigators aim to assess whether there is an improvement in various cardiopulmonary exercise testing (CPET) variables such as maximum oxygen consumption and anaerobic threshold. The investigators also aim to study the inflammatory cytokines associated with cancer and how these markers respond to exercise. These inflammatory markers are thought to play a role in influencing some clinical outcomes such as wound infection and recovery.

The study will also assess secondary outcomes including hospital stay, post operative complications and quality of life. The investigators aim to better understand the biological relationship between anti-inflammatory cytokine levels and the previously mentioned outcomes by measuring and analysing these mediators and performing selected muscle biopsies.

Details
Condition Cancer of Colon, Cancer of Rectum, Liver Metastases
Treatment Prehabilitation
Clinical Study IdentifierNCT04880772
SponsorEast Lancashire Hospitals NHS Trust
Last Modified on9 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 18-85
Sex: male/female
Radiological/tissue cancer diagnosis
Curative cancer of the colon, rectum, colorectal liver metastases (CRLM) of 2 or more segments
elective surgery (planned a minimum of 3 weeks from the date of first clinic meeting)
Access to digital technology(mobile phone, tablet or laptop, home computer) to participate in supervised home exercise

Exclusion Criteria

Exclusion
Palliative disease
Haematological malignancy
Pregnancy
Emergency surgery
Physically unable to undergo CPET
Part of any other trial with similar interventions unless previously agreed on with all CIs
synchronous disease (operation on HPB & colorectal cancers at the same operation)
No access to digital technology(smart phone, tablet, laptop or home computer)
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