Colorectal CancerPEACOCSNCT02264496
Prospective Randomised Trial of Exercise and / or Antioxidants in COlorectal Cancer Patients Undergoing Surgery.
A study testing Exercise in people with Colorectal Cancer, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Colorectal cancer is the fourth most common cancer in the UK. Surgical resection is the mainstay of curative therapy. With the screening program enabling early detection, surgery plays an important role in treatment strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Nov 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with colorectal cancer listed for elective resection surgery who have consented to participate in the study.
Who cannot join
- History of unstable angina/unstable coronary artery disease or a heart attack in the previous month
- Any heart related disease including but not limited to aortic stenosis, pericarditis or any thromboembolic disease
- Severe Infections and fever
- Uncontrolled metabolic diseases
- Uncontrolled asthma
- Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
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- Resting heart rate of more than 120 BPM
- Systolic blood pressure of more than 180 mm Hg or diastolic blood pressure of more than 110 mm Hg
- Recent cerebrovascular accident
- Pregnancy
- Preexisting severe physical disability
- Age <18 years
- Unwilling to allow their GP to be informed of their participation in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Academic Surgical Unit, Castle Hill Hospital
Hull, East Yorkshire, HU16 5JQ
About this study
Official title: The Effects of Exercise on Outcomes in Patients Undergoing Surgery for Colorectal Cancer: a Pilot Prospective Randomised Trial.
Colorectal cancer is the fourth most common cancer in the UK. Surgical resection is the mainstay of curative therapy. With the screening program enabling early detection, surgery plays an important role in treatment strategies. Surgery imparts a significant physiological and psychological stress on cancer patients.Recent research has demonstrated that a fast-track approach utilising regional anaesthesia, early mobilisation and good oral intake can improve outcomes by reducing the physiological stress response to surgery. The primary objective of this study is to determine whether a defined exercise programme can improve recovery and reduce complications after surgery.
Read the detailed description
Study Design
This will be a prospective and randomised pilot clinical trial. For purposes of pragmatism, subjects and investigators will not be blinded to treatment allocation. The study is not blinded because it is impossible to blind investigators or patients to the exercise programme.
Patients undergoing major resectional surgery for colorectal cancer will be recruited from the Academic Surgical unit (ASU), Castle Hill Hospital. In total, 60 participants will be recruited for this pilot study and randomly allocated into 2 groups as outlined below.
The study will necessitate all participants being involved in a baseline assessment which will take on average 60 minutes with patients attending Castle Hill Hospital. Travel costs will be met.
All participants will be asked for a 15 ml blood samples on entry into the study and at 24-48 hrs prior to surgery. Regardless of recruitment, blood samples are necessary for clinical purposes at these stages in all patients as part of routine preoperative assessment prior to colorectal surgery. The aim of this is to permit an analysis of possible changes in antioxidant status prior to surgery but after preconditioning. This would be in addition to routine blood samples required.
The two groups in this study are described in more detail below. Both groups shall receive the same standard care as is normal for patients undergoing colorectal resection surgery. The only difference between groups shall be the addition of exercise preconditioning sessions to group 1. We anticipate that these will be three times a week and lasting of 60-90 minutes duration each. Travel costs will be met.
Groups
The 60 patients in this study will be randomised to one of two groups as follows:
- Group 1 - Standard care + Exercise intervention. Patients in this group will participate in a 2-4 week low volume, moderate intensity, supervised, one to one, individualised exercise programme.
- Group 2 - Standard care (Control) group. These patients will not be entered into a supervised exercise programme.
Research hypothesis 1
H0 - A two to four week period of low to moderate intensity exercise prior to surgery using an individualised exercise intervention will not reduce post-surgical length of hospital stay in colorectal cancer patients.
H1- A two to four week period of low to moderate intensity exercise prior to surgery using an individualised exercise intervention will reduce post-surgical length of hospital stay in colorectal cancer patients.
Research hypothesis 2
H0 - A two to four week period of low to moderate intensity exercise prior to surgery using an individualised exercise intervention will not modify the body's defence systems against a future oxidative stress.
H1- A two to four week period of low to moderate intensity exercise prior to surgery using an individualised exercise intervention will modify the body's defence systems against a future oxidative stress.
- Conditions
- Colorectal Cancer
- Being tested
- Exercise
- Keywords
- Colorectal cancer, Exercise, CPEX, Exercise, Physical, Exercise, Aerobic, Surgery
- Medical subject headings
- Colorectal Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard pre-operative care |
| Exercise | Experimental | A 2-4 week low volume, moderate intensity, supervised, one to one, individualised exercise programme. ' Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Post-operative hospital length of stay until medically fit for discharge.
Measured: Up to 3 months
Secondary outcomes (4)
Antioxidant capacity
Biochemical markers of antioxidant capacity: Hsp 32/72, CD11b/CD18 and Glutathione measured pre- and post-intervention.
Measured: Up to 4 weeks
Exercise capacity
Exercise test and CPEX parameters assessed pre-intervention, post-intervention and at 3 months post surgery.
Measured: Up to 3 months
Complications
All post-operative complications assessed at 3 months post surgery.
Measured: Up to 3 months
Quality of Life Questionnaires
Validated QOL questionnaires completed pre-intervention, post-intervention and at 3 months post surgery.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Hull
- Responsible party
- Sponsor
- Investigators
- John Hartley, MD FRCS, Principal investigator, Hull and East Yorkshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264496
- Sponsor's protocol ID
- 13/YH/0322 V3
- Acronym
- PEACOCS
- Status last verified
- Jul 2019
- First submitted
- 7 Oct 2014
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise on Outcomes in Patients Undergoing Surgery for Colorectal Cancer: a Pilot Prospective Randomised Trial.
- ClinicalTrials.gov ID
- NCT02264496
- Acronym / sponsor ID
- PEACOCS / 13/YH/0322 V3
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Exercise, CPEX, Exercise, Physical, Exercise, Aerobic, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- University of Hull
- Study start
- Mar 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 15 Oct 2014 (estimated)
- 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.
Colorectal cancer is the fourth most common cancer in the UK. Surgical resection is the mainstay of curative therapy. With the screening program enabling early detection, surgery plays an important role in treatment strategies. Surgery imparts a significant physiological and psychological stress on cancer patients.Recent research has demonstrated that a fast-track approach utilising regional anaesthesia, early mobilisation and good oral intake can improve outcomes by reducing the physiological stress response to surgery. The primary objective of this study is to determine whether a defined exercise programme can improve recovery and reduce complications after surgery.
Detailed description
Study Design
This will be a prospective and randomised pilot clinical trial. For purposes of pragmatism, subjects and investigators will not be blinded to treatment allocation. The study is not blinded because it is impossible to blind investigators or patients to the exercise programme.
Patients undergoing major resectional surgery for colorectal cancer will be recruited from the Academic Surgical unit (ASU), Castle Hill Hospital. In total, 60 participants will be recruited for this pilot study and randomly allocated into 2 groups as outlined below.
The study will necessitate all participants being involved in a baseline assessment which will take on average 60 minutes with patients attending Castle Hill Hospital. Travel costs will be met.
All participants will be asked for a 15 ml blood samples on entry into the study and at 24-48 hrs prior to surgery. Regardless of recruitment, blood samples are necessary for clinical purposes at these stages in all patients as part of routine preoperative assessment prior to colorectal surgery. The aim of this is to permit an analysis of possible changes in antioxidant status prior to surgery but after preconditioning. This would be in addition to routine blood samples required.
The two groups in this study are described in more detail below. Both groups shall receive the same standard care as is normal for patients undergoing colorectal resection surgery. The only difference between groups shall be the addition of exercise preconditioning sessions to group 1. We anticipate that these will be three times a week and lasting of 60-90 minutes duration each. Travel costs will be met.
Groups
The 60 patients in this study will be randomised to one of two groups as follows:
- Group 1 - Standard care + Exercise intervention. Patients in this group will participate in a 2-4 week low volume, moderate intensity, supervised, one to one, individualised exercise programme.
- Group 2 - Standard care (Control) group. These patients will not be entered into a supervised exercise programme.
Research hypothesis 1
H0 - A two to four week period of low to moderate intensity exercise prior to surgery using an individualised exercise intervention will not reduce post-surgical length of hospital stay in colorectal cancer patients.
H1- A two to four week period of low to moderate intensity exercise prior to surgery using an individualised exercise intervention will reduce post-surgical length of hospital stay in colorectal cancer patients.
Research hypothesis 2
H0 - A two to four week period of low to moderate intensity exercise prior to surgery using an individualised exercise intervention will not modify the body's defence systems against a future oxidative stress.
H1- A two to four week period of low to moderate intensity exercise prior to surgery using an individualised exercise intervention will modify the body's defence systems against a future oxidative stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard pre-operative care |
| Exercise | Experimental | Behavioral: ExerciseA 2-4 week low volume, moderate intensity, supervised, one to one, individualised exercise programme. ' |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with colorectal cancer listed for elective resection surgery who have consented to participate in the study.
Key exclusion criteria (13 listed)
- History of unstable angina/unstable coronary artery disease or a heart attack in the previous month
- Any heart related disease including but not limited to aortic stenosis, pericarditis or any thromboembolic disease
- Severe Infections and fever
- Uncontrolled metabolic diseases
- Uncontrolled asthma
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 |
|---|---|---|
| Exercise | Behavioural | Exercise |
Primary outcome
Length of stay
Time frame: Up to 3 months
Post-operative hospital length of stay until medically fit for discharge.
4 secondary outcomes
Antioxidant capacity
Time frame: Up to 4 weeks
Exercise capacity
Time frame: Up to 3 months
Complications
Time frame: Up to 3 months
Quality of Life Questionnaires
Time frame: Up to 3 months
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 15 Jul 2019.
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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.
John Hartley, MD FRCS principal investigator
Hull and East Yorkshire NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Colorectal Cancer, run by Hull University Teaching 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 1 inclusion and 13 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 15 Jul 2019. 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?
Length of stay (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2019.