- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02264496
Prospective Randomised Trial of Exercise and / or Antioxidants in COlorectal Cancer Patients Undergoing Surgery. (PEACOCS)
The Effects of Exercise on Outcomes in Patients Undergoing Surgery for Colorectal Cancer: a Pilot Prospective Randomised Trial.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
East Yorkshire
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Hull, East Yorkshire, United Kingdom, HU16 5JQ
- Academic Surgical Unit, Castle Hill Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult patients with colorectal cancer listed for elective resection surgery who have consented to participate in the study.
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Standard pre-operative care
|
|
Experimental: Exercise
A 2-4 week low volume, moderate intensity, supervised, one to one, individualised exercise programme.
'
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay
Time Frame: Up to 3 months
|
Post-operative hospital length of stay until medically fit for discharge.
|
Up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antioxidant capacity
Time Frame: Up to 4 weeks
|
Biochemical markers of antioxidant capacity: Hsp 32/72, CD11b/CD18 and Glutathione measured pre- and post-intervention.
|
Up to 4 weeks
|
Exercise capacity
Time Frame: Up to 3 months
|
Exercise test and CPEX parameters assessed pre-intervention, post-intervention and at 3 months post surgery.
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Up to 3 months
|
Complications
Time Frame: Up to 3 months
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All post-operative complications assessed at 3 months post surgery.
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Up to 3 months
|
Quality of Life Questionnaires
Time Frame: Up to 3 months
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Validated QOL questionnaires completed pre-intervention, post-intervention and at 3 months post surgery.
|
Up to 3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: John Hartley, MD FRCS, Hull and East Yorkshire NHS Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13/YH/0322 V3
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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