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

Liver Metastases Clinical Trial

— SPECS  

Official title:

A Single-centre Two-armed Randomised Controlled Trial Comparing Standard Care Alone Versus Exercise and Nutrition Prehabilitation in Elective Patients Undergoing Resectional HPB and Colorectal Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04880772
• Other study ID #: 290723
• Status: Completed
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: July 13, 2023

Study information

• Verified date: September 2023
• Source: East Lancashire Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 13, 2023
• Est. primary completion date: July 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cancer of Colon
• Cancer of Rectum
• Colonic Neoplasms
• Liver Metastases
• Rectal Neoplasms

Intervention

Other:
• Prehabilitation
exercise & multivitamin (nutritional/dietary advice)

Locations

Country	Name	City	State
United Kingdom	Royal Blackburn Hospital	Blackburn

Sponsors (2)

Lead Sponsor	Collaborator
East Lancashire Hospitals NHS Trust	Lancaster University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Lambert JE, Hayes LD, Keegan TJ, Subar DA, Gaffney CJ. The Impact of Prehabilitation on Patient Outcomes in Hepatobiliary, Colorectal, and Upper Gastrointestinal Cancer Surgery: A PRISMA-Accordant Meta-analysis. Ann Surg. 2021 Jul 1;274(1):70-77. doi: 10.1097/SLA.0000000000004527. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anaerobic threshold (AT) measured in ml/kg/min and maximum oxygen consumption ( VO2 peak) measured in ml/kg/min	Cardiopulmonary exercise Test (CPET) variables	change in baseline AT & VO2 peak at 4 weeks
Primary	Inflammatory cytokines	IL6 IL10 in muscle and blood measured in pg/ml	change in baseline cytokines at 4 weeks
Secondary	Clavien-Dindo complication rates	Grades I-IV	Up to 30 days from the day of operation
Secondary	Length of hospital stay measured in days	Defined as duration of stay from date of operation to discharge	30 & 90-day mortality
Secondary	Quality of life measures (Illness Perception Questionnaire)	This questionnaire assesses perceptions on each of the five dimensions(Identity, Cause, Timeline, Consequences, Cure-Control) by asking patients for their own beliefs about their condition.; High scores on the identity, consequences, timeline acute/ chronic and cyclical subscales represent strongly held beliefs about the number of symptoms attributed, the negative consequences, and the chronicity and cyclical nature of the illness.; High scores on the identity and cure-control and coherence subscales represent positive beliefs about controllability and a personal understanding of the illness.	baseline and within 24 weeks after surgery
Secondary	Hand Grip Strength measured in kg	Measured by digital dynamometer	baseline, immediately after the intervention, within 24 weeks after surgery
Secondary	Quality of life measure (Mental Adjustment to Cancer Scale)	Assessment of participants mental adjustment to a cancer diagnosis. Designed to measure Fighting Spirit (FS), Anxious Preoccupation (AP), Helpless-hopelessness (HH) and Fatalism. This is a 40-item measure of specific psychological (Coping) responses that cancer patients may display in the process of adjusting to the diagnosis and treatment of their disease.; A higher score represents higher endorsement of the adjustment response.	baseline and within 24 weeks after surgery

External Links

•   study website