Cancer of ColonSPECSNCT04880772
Clinical Trial Comparing Standard Care Versus Prehabilitation in Patients Undergoing Cancer Surgery
A study testing Prehabilitation in people with Cancer of Colon and Cancer of Rectum, run by East Lancashire Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
To determine whether exercise and nutrition prehabilitation improves patient outcomes after cancer surgery Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cancer of Colon, Cancer of Rectum, Liver Metastases
- What is being tested?
- Prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jul 2021to 13 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
To determine whether exercise and nutrition prehabilitation improves patient outcomes after cancer surgery
Read the 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.
- Conditions
- Cancer of Colon, Cancer of Rectum, Liver Metastases
- Being tested
- Prehabilitation
- Keywords
- prehabilitation, surgery, cardiopulmonary exercise testing, cytokines
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
exercise \& multivitamin (nutritional/dietary advice)
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | 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 | Surgery School plus Moderate intensity exercise \& Forceval (multivitamin) Receives: Other: Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anaerobic threshold (AT) measured in ml/kg/min and maximum oxygen consumption ( VO2 peak) measured in ml/kg/min
Cardiopulmonary exercise Test (CPET) variables
Measured: change in baseline AT & VO2 peak at 4 weeks
Inflammatory cytokines
IL6 IL10 in muscle and blood measured in pg/ml
Measured: change in baseline cytokines at 4 weeks
Secondary outcomes (5)
Clavien-Dindo complication rates
Grades I-IV
Measured: Up to 30 days from the day of operation
Length of hospital stay measured in days
Defined as duration of stay from date of operation to discharge
Measured: 30 & 90-day mortality
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.
Measured: baseline and within 24 weeks after surgery
Hand Grip Strength measured in kg
Measured by digital dynamometer
Measured: baseline, immediately after the intervention, within 24 weeks after surgery
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.
Measured: baseline and within 24 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start15 Jul 2021
- Primary completion13 Jul 2023
- Study completion13 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of ColonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomisation to standard care or prehabilitation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Lancashire Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Lancaster University
- Responsible party
- Principal investigator, Joel Lambert, East Lancashire Hospitals NHS Trust
- Investigators
- Joel Lambert, Principal investigator, Senior Clinical Research FellowChris Gaffney, Study director, Lancaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880772
- Sponsor's protocol ID
- 290723
- Acronym
- SPECS
- Status last verified
- Sep 2023
- First submitted
- 27 Apr 2021
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised CPET data to be shared with other researchers. Anonymised tissue and blood samples to be shared with other researchers for analysis
Publications
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.
PubMed 33201129
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04880772
- Acronym / sponsor ID
- SPECS / 290723
- Conditions
- Cancer of Colon, Cancer of Rectum, Liver Metastases
- Keywords
- prehabilitation, surgery, cardiopulmonary exercise testing, cytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- East Lancashire Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Lancaster University
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 13 Jul 2023 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether exercise and nutrition prehabilitation improves patient outcomes after cancer surgery
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomisation to standard care or prehabilitation
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –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 | Other: PrehabilitationSurgery School plus Moderate intensity exercise \& Forceval (multivitamin) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- Palliative disease
- Haematological malignancy
- Pregnancy
- Emergency surgery
- Physically unable to undergo CPET
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitationexercise \& multivitamin (nutritional/dietary advice) | Other | Prehabilitation |
Primary outcome
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
Inflammatory cytokines
Time frame: change in baseline cytokines at 4 weeks
IL6 IL10 in muscle and blood measured in pg/ml
5 secondary outcomes
Clavien-Dindo complication rates
Time frame: Up to 30 days from the day of operation
Length of hospital stay measured in days
Time frame: 30 & 90-day mortality
Quality of life measures (Illness Perception Questionnaire)
Time frame: 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
Quality of life measure (Mental Adjustment to Cancer Scale)
Time frame: baseline and within 24 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Background: PubMed 33201129Lambert 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.
- study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymised CPET data to be shared with other researchers. Anonymised tissue and blood samples to be shared with other researchers for analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Lambert principal investigator
Senior Clinical Research Fellow
Chris Gaffney study director
Lancaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Cancer of Colon and Cancer of Rectum, run by East Lancashire Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04880772, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.