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

September 5, 2023 updated by: Joel Lambert, East Lancashire Hospitals NHS Trust

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Blackburn, United Kingdom, BB@ 3HH
        • Royal Blackburn Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard care
Standard Care: Surgery school as per ELHT pre-operative guidelines (includes generic pre-operative information, advice and optimisation e.g correction of anaemia)
Experimental: Prehabilitation
Surgery School plus Moderate intensity exercise & Forceval (multivitamin)
Other: Prehabilitation
exercise & multivitamin (nutritional/dietary advice)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anaerobic threshold (AT) measured in ml/kg/min and maximum oxygen consumption ( VO2 peak) measured in ml/kg/min
Time Frame: change in baseline AT & VO2 peak at 4 weeks
Cardiopulmonary exercise Test (CPET) variables
change in baseline AT & VO2 peak at 4 weeks
Inflammatory cytokines
Time Frame: change in baseline cytokines at 4 weeks
IL6 IL10 in muscle and blood measured in pg/ml
change in baseline cytokines at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clavien-Dindo complication rates
Time Frame: Up to 30 days from the day of operation
Grades I-IV
Up to 30 days from the day of operation
Length of hospital stay measured in days
Time Frame: 30 & 90-day mortality
Defined as duration of stay from date of operation to discharge
30 & 90-day mortality
Quality of life measures (Illness Perception Questionnaire)
Time Frame: baseline and within 24 weeks after surgery

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
Hand Grip Strength measured in kg
Time Frame: baseline, immediately after the intervention, within 24 weeks after surgery
Measured by digital dynamometer
baseline, immediately after the intervention, within 24 weeks after surgery
Quality of life measure (Mental Adjustment to Cancer Scale)
Time Frame: baseline and within 24 weeks after surgery

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Lancashire Hospitals NHS Trust

Collaborators

Lancaster University

Investigators

  • Principal Investigator: Joel Lambert, Senior Clinical Research Fellow
  • Study Director: Chris Gaffney, Lancaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2021

Primary Completion (Actual)

July 13, 2023

Study Completion (Actual)

July 13, 2023

Study Registration Dates

First Submitted

April 27, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 290723

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymised CPET data to be shared with other researchers. Anonymised tissue and blood samples to be shared with other researchers for analysis

IPD Sharing Time Frame

18 months

IPD Sharing Access Criteria

Full anonymisation

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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