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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
East Lancashire Hospitals NHS Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lancaster University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Liver Metastases

Clinical Trials on Prehabilitation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings