Colorectal CancerEDICTNCT02056691
EDICT - Exercise inDuced Changes In Colorectal Cancer Tissues
A study testing Exercise programme and Muscle biopsy in people with Colorectal Cancer, run by The Royal Bournemouth Hospital at 2 sites in United Kingdom.
Trial summary
This pilot study looks to explore the biological effects of exercise on cancer and muscle cells using a two week exercise program (HIThigh intensity training) on 20 patients with newly diagnosed and operable colorectal cancer following diagnosis and prior to surgery. Maximal oxygen uptake will also be measured. 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 programme and Muscle biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2014to 30 Oct 2017
- 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
- Colorectal cancer confirmed by histology
- Considered fit for surgery by surgical and anaesthetic team
- Considered fit for physical activity programme by MDT
- Age ≥ 18 years
- BMI ≥ 26 kg/m2
- Not pregnant
Show all 9Show fewer
- Non obstructing cancer
- Able to provide written informed consent
- Patients not having neoadjuvant chemotherapy
Who cannot join
- Receiving hormone therapy
- Patients with diabetes
- Patients currently on either a dietary or exercise programme reflective of the World Cancer Research Fund Guidelines.
- Cardiac or renal impairment
- Excessive use of laxatives
- History of eating disorders
Show all 9Show fewer
- Patients with inflammatory bowel disorders/coeliac
- Strong family history/polyposis (i.e. more than one 1st degree relative <55yrs)
- Patients with previous or concurrent malignancies
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
The Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW
Poole Hospital
Poole, Dorset, BH15 2JB
About this study
Official title: Clinical and Biological Effects of a Preoperative Exercise Programme in Colorectal Tumour and Skeletal Muscle Tissues (Exercise inDuced Changes In Colorectal Cancer Tissues)
This pilot study looks to explore the biological effects of exercise on cancer and muscle cells using a two week exercise program (HIThigh intensity training) on 20 patients with newly diagnosed and operable colorectal cancer following diagnosis and prior to surgery. Maximal oxygen uptake will also be measured. The aim of this pilot is to assess the feasibility of recruiting participants to and carrying out a two week preoperative exercise program in patients with colorectal cancer.
Read the detailed description
Patients undergoing investigation for symptoms of colorectal cancer presenting to the hospital will undergo standard diagnostic procedures. Once resectable nonmetastatic cancer has been diagnosed (i.e. cancer that has not spread beyond the bowel), is amenable to surgical resection as decided by the colorectal multidisciplinary and if the patient fulfills the selection criteria, they will be asked if they wish to participate in the study. They will be given information regarding the study at the time of diagnosis. If they give their consent then a formal consenting process will take place at the next routine appointment.
During this appointment the patient will have the opportunity to ask questions. A member of the study team will explain the study in detail, answer any questions potential participants (and their partners/ carers) have. The patient is free to refuse participation or withdraw from the study at any time without this affecting their care, this is explained in the information and will be discussed further at the time of informed consent. If the patient agrees to participate in the trial, following the provision of informed consent and before embarking on the exercise programme they will need to fill in two questionnaires, the International Physical Activity Questionnaire (Long) and Dietary Intervention in Primary Care Questionnaire (DINE). They will be counseled to try and maintain their normal exercise level and their calorie intake. Blood samples will also be taken, analyzed and stored for further analysis including possible genetic analysis at a later stage before starting the exercise regime. They will have a muscle biopsy under local anaesthetic taken from the thigh, again for analysis and storage.
Participants will undergo an initial assessment of their baseline exercise ability and oxygen absorption using an upright exercise bike with concurrent ECG readings and breath analysis. The two week preoperative exercise regime will be planned depending on the patient's operation date. The exercise regime consists of 10 sessions of exercise against a constant load, each lasting 60s, separated by 60s of recovery eliciting 90% maximal heart rate.
The 6 sessions are held over a 2 week period. Each patients exercise ability and oxygen absorption will be remeasured at the end of the 2 week period and a second sample of blood taken for comparison. During the operation a sample of adipose tissue near the tumour site will be taken separately to the main sample. A muscle biopsy from the thigh will also be taken at the same time. As a standard of clinical care all patients are reviewed in the outpatient setting 6 weeks postoperatively. When patients attend this follow up appointment a final blood test and muscle biopsy (under local anaesthetic) will be taken to assess the longer term effects of the exercise program. Patient consent will be sought for this separately although it will be discussed at the initial introduction to the study.
Patients are free to withdraw from the study at any time and if there are any adverse events or concerns regarding the continuation of the study for a patient then they will be withdrawn.
- Conditions
- Colorectal Cancer
- Being tested
- Exercise programme, Muscle biopsy
- Keywords
- Resectable, non-metastatic, colorectal, carcinoma, cancer, neoplasm, exercise, effects, program, pre-operative, proliferation, diagnosed, surgery, biopsy, muscle, signalling, IGF1, ki67, p53, response
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Neoplasms, Motor Activity, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programmeProcedure or surgery
The exercise regime consists of 10 sessions of exercise against a constant load, each lasting 60 seconds, separated by 60 seconds of recovery eliciting 90% maximal heart rate. The 6 sessions are held over a 2 week period.
Muscle biopsyProcedure or surgery
muscle biopsy under local anaesthetic taken from the thigh, again for analysis and storage 3 times: before, during and after the exercise programme
| Study group | Role | What they receive |
|---|---|---|
| Exercise programme | Experimental | Exercise programme Muscle biopsies Receives: Procedure: Exercise programme; Procedure: Muscle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the feasibility of carrying out a two week preoperative exercise program in patients with colorectal cancer and assess the effects of preoperative exercise on the proliferation of colorectal cancer cells
To assess the feasibility of carrying out a two week preoperative exercise program in patients with colorectal cancer and to assess the effects of preoperative exercise on the proliferation of colorectal cancer cells by measuring the change in the percentage of cells staining positive for Ki67 (a measure of cell proliferation).
Measured: 1 year
Secondary outcomes (11)
Changes in molecular markers for the effects of exercise and/or diet on AMPK/ mammilian target of rapamycin signalling pathway
Measuring changes in molecular markers for the effects of exercise and/or diet on AMPK/mTOR signalling pathway (phosphorylated 4EBP1 (P4EBP1), phosphorylated protein kinase B (PPKB/AKT), and phosphorylated AMPK (PAMPK).
Measured: 12 weeks
Changes in AKT expression normal colonic tissue
Measuring changes in AKT expression normal colonic tissue - Intensity of AKT1/AKT2 staining, or AKT phosphorylation, a marker of insulin receptor signalling in cells.
Measured: 12 weeks
Assessing Apoptosis index
Assessing Apoptosis index - Percentage of tumour cells staining positive for DNA fragmentation, a marker of cells undergoing apoptosis and therefore cell death.
Measured: 12 weeks
Changes in molecular markers that may mediate or modify exercise/dietary effects in tumour tissues
Measuring changes in molecular markers that may mediate or modify exercise/dietary effects in tumour tissues (IR, IGF1R, p53 and its transcriptional target p21, ER, progesterone receptor, tumor necrosis factor-alpha converting enzyme and TIMP3).
Measured: 12 weeks
Assessing gene expression profiles
Assessing gene expression profiles focusing on gene associated with insulin resistance.
Measured: 12 weeks
Assessing the 11 gene signature
Assessing the 11 gene signature that help to predict maximal oxygen uptake gain in patients before and after exercise
Measured: 12 weeks
Blood methylation profiles.
Blood methylation profiles.
Measured: 12 weeks
Cortisol levels
Cortisol levels to evaluate levels of biological stress.
Measured: 12 weeks
Postoperative complications up to 30 days postoperatively
Postoperative complications up to 30 days postoperatively
Measured: 30 days post op
Moderator variables
Moderator variables including state of motivational readiness for exercise, weight change, depression and anxiety
Measured: 12 weeks
Irisin levels
Irisin levels before and after exercise
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startOct 2014
- Primary completion19 Sep 2017
- Study completion30 Oct 2017
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Bournemouth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamas Hickish, FRCP, Principal investigator, The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056691
- Sponsor's protocol ID
- ed-1
- Acronym
- EDICT
- Status last verified
- Mar 2018
- First submitted
- 5 Feb 2014
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biological Effects of a Preoperative Exercise Programme in Colorectal Tumour and Skeletal Muscle Tissues (Exercise inDuced Changes In Colorectal Cancer Tissues)
- ClinicalTrials.gov ID
- NCT02056691
- Acronym / sponsor ID
- EDICT / ed-1
- Conditions
- Colorectal Cancer
- Keywords
- Resectable, non-metastatic, colorectal, carcinoma, cancer, neoplasm, exercise, effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The Royal Bournemouth HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 19 Sep 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 6 Feb 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.
This pilot study looks to explore the biological effects of exercise on cancer and muscle cells using a two week exercise program (HIThigh intensity training) on 20 patients with newly diagnosed and operable colorectal cancer following diagnosis and prior to surgery. Maximal oxygen uptake will also be measured. The aim of this pilot is to assess the feasibility of recruiting participants to and carrying out a two week preoperative exercise program in patients with colorectal cancer.
Detailed description
Patients undergoing investigation for symptoms of colorectal cancer presenting to the hospital will undergo standard diagnostic procedures. Once resectable nonmetastatic cancer has been diagnosed (i.e. cancer that has not spread beyond the bowel), is amenable to surgical resection as decided by the colorectal multidisciplinary and if the patient fulfills the selection criteria, they will be asked if they wish to participate in the study. They will be given information regarding the study at the time of diagnosis. If they give their consent then a formal consenting process will take place at the next routine appointment.
During this appointment the patient will have the opportunity to ask questions. A member of the study team will explain the study in detail, answer any questions potential participants (and their partners/ carers) have. The patient is free to refuse participation or withdraw from the study at any time without this affecting their care, this is explained in the information and will be discussed further at the time of informed consent. If the patient agrees to participate in the trial, following the provision of informed consent and before embarking on the exercise programme they will need to fill in two questionnaires, the International Physical Activity Questionnaire (Long) and Dietary Intervention in Primary Care Questionnaire (DINE). They will be counseled to try and maintain their normal exercise level and their calorie intake. Blood samples will also be taken, analyzed and stored for further analysis including possible genetic analysis at a later stage before starting the exercise regime. They will have a muscle biopsy under local anaesthetic taken from the thigh, again for analysis and storage.
Participants will undergo an initial assessment of their baseline exercise ability and oxygen absorption using an upright exercise bike with concurrent ECG readings and breath analysis. The two week preoperative exercise regime will be planned depending on the patient's operation date. The exercise regime consists of 10 sessions of exercise against a constant load, each lasting 60s, separated by 60s of recovery eliciting 90% maximal heart rate.
The 6 sessions are held over a 2 week period. Each patients exercise ability and oxygen absorption will be remeasured at the end of the 2 week period and a second sample of blood taken for comparison. During the operation a sample of adipose tissue near the tumour site will be taken separately to the main sample. A muscle biopsy from the thigh will also be taken at the same time. As a standard of clinical care all patients are reviewed in the outpatient setting 6 weeks postoperatively. When patients attend this follow up appointment a final blood test and muscle biopsy (under local anaesthetic) will be taken to assess the longer term effects of the exercise program. Patient consent will be sought for this separately although it will be discussed at the initial introduction to the study.
Patients are free to withdraw from the study at any time and if there are any adverse events or concerns regarding the continuation of the study for a patient then they will be withdrawn.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise programme | Experimental | Procedure: Exercise programme, Procedure: Muscle biopsyExercise programme Muscle biopsies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Colorectal cancer confirmed by histology
- Considered fit for surgery by surgical and anaesthetic team
- Considered fit for physical activity programme by MDT
- Age ≥ 18 years
- BMI ≥ 26 kg/m2
Key exclusion criteria (9 listed)
- Receiving hormone therapy
- Patients with diabetes
- Patients currently on either a dietary or exercise programme reflective of the World Cancer Research Fund Guidelines.
- Cardiac or renal impairment
- Excessive use of laxatives
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 programmeThe exercise regime consists of 10 sessions of exercise against a constant load, each lasting 60 seconds, separated by 60 seconds of recovery eliciting 90% maximal heart rate. The 6 sessions are held over a 2 week period. | Procedure or surgery | Exercise programme |
| Muscle biopsymuscle biopsy under local anaesthetic taken from the thigh, again for analysis and storage 3 times: before, during and after the exercise programme | Procedure or surgery | Exercise programme |
Primary outcome
Assess the feasibility of carrying out a two week preoperative exercise program in patients with colorectal cancer and assess the effects of preoperative exercise on the proliferation of colorectal cancer cells
Time frame: 1 year
To assess the feasibility of carrying out a two week preoperative exercise program in patients with colorectal cancer and to assess the effects of preoperative exercise on the proliferation of colorectal cancer cells by measuring the change in the percentage of cells staining positive for Ki67 (a measure of cell proliferation).
11 secondary outcomes
Changes in molecular markers for the effects of exercise and/or diet on AMPK/ mammilian target of rapamycin signalling pathway
Time frame: 12 weeks
Changes in AKT expression normal colonic tissue
Time frame: 12 weeks
Assessing Apoptosis index
Time frame: 12 weeks
Changes in molecular markers that may mediate or modify exercise/dietary effects in tumour tissues
Time frame: 12 weeks
Assessing gene expression profiles
Time frame: 12 weeks
Assessing the 11 gene signature
Time frame: 12 weeks
Blood methylation profiles.
Time frame: 12 weeks
Cortisol levels
Time frame: 12 weeks
Postoperative complications up to 30 days postoperatively
Time frame: 30 days post op
Moderator variables
Time frame: 12 weeks
Irisin levels
Time frame: 12 weeks
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 13 Mar 2018.
Related trials for Colorectal Cancer
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
RecruitingPhase 1
Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer
Phase 1, SAR445877
Recruiting
Addressing Disparities in Colorectal Cancer Screening in Black and Underserved Phoenix Communities
Colorectal Carcinoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruiting
Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas
Colorectal Cancer (CRC) Screening
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.
Tamas Hickish, FRCP principal investigator
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise programme and Muscle biopsy in people with Colorectal Cancer, run by The Royal Bournemouth Hospital at 2 sites 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 9 inclusion and 9 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 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Assess the feasibility of carrying out a two week preoperative exercise program in patients with colorectal cancer and assess the effects of preoperative exercise on the proliferation of colorectal cancer cells (time frame: 1 year). 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 13 Mar 2018; AzTrials last refreshed its copy on 3 Nov 2026.