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

East Lancashire Hospitals NHS Trust

Status: Completed

Conditions: Cancer of Rectum; Cancer of Colon; Liver Metastases

Treatments: Other: Prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04880772

290723

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Standard care

No Intervention group

Description:

Standard Care: Surgery school as per ELHT pre-operative guidelines (includes generic pre-operative information, advice and optimisation e.g correction of anaemia)

Prehabilitation

Experimental group

Description:

Surgery School plus Moderate intensity exercise \& Forceval (multivitamin)

Treatment:

Other: Prehabilitation