Colorectal CancerNCT00833508
Effect of Preoperative Chemoradiotherapy on Exercise Capacity as Measured by Cardiopulmonary Exercise Testing
A study testing Cardiopulmonary exercise testing in people with Colorectal Cancer, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This study will investigate the effect of preoperative chemoradiotherapy on exercise capacity as measured by cardiopulmonary exercise testing in patients with colorectal cancer. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Cardiopulmonary exercise testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2009to Oct 2011
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age greater than 65
- Colorectal cancer requiring preoperative chemoradiotherapy
Who cannot join
- Inability to walk, or exercise on a bicycle or treadmill
- Inability to understand instructions for CPET testing
- ASA grade 4 or 5 (indicating severe cardiovascular co-morbidity and not expected to survive surgery)
- Contraindications to Exercise Testing
- Myocardial infarction occurring 10 days or less before CPX testing
- Symptomatic arrythmias
Show all 16Show fewer
- Left Main Stem coronary disease of >50%
- Severe hypertension (SBP>180mmHg)
- Resting SpO2 <85%
- Acute cardiac inflammatory conditions (myocarditis, pericarditis)
- Unstable angina with symptoms within 4 days
- Dissecting aneurysm of aorta
- Acute pyrexial illness
- Thyrotoxicosis
- Syncopal episodes
- Lower limb thrombosis (arterial or venous)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial NHS Trust, St Mary's Hospital, Praed Street
London, W2 1NY
About this study
This study will investigate the effect of preoperative chemoradiotherapy on exercise capacity as measured by cardiopulmonary exercise testing in patients with colorectal cancer.
Read the detailed description
Chemoradiotherapy is associated with adverse effects. Patients with certain colorectal cancers undergo chemoradiotherapy prior to surgical resection. We intend to assess patient exercise capacity before and after chemoradiotherapy to assess whether this deteriorates. If there is a deleterious effect, this may affect operative outcome.
- Conditions
- Colorectal Cancer
- Being tested
- Cardiopulmonary exercise testing
- Keywords
- Exercise capacity, Chemoradiotherapy, Colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary exercise testingOther
Cardiopulmonary exercise testing involves cycling on an exercise bicycle whilst oxygen consumption and carbon dioxide generation are measured from expired gases. This is used to calculate patient fitness from their peak oxygen consumption and their anaerobic threshold.
| Study group | Role | What they receive |
|---|---|---|
| Test arm | Experimental | Patients undergoing preoperative chemoradiotherapy will have their exercise capacity measured before and after chemoradiotherapy. Receives: Other: Cardiopulmonary exercise testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Anaerobic threshold of 1.5ml/min/kg or more
Measured: 6 weeks
Secondary outcomes (1)
Operative outcome
Measured: 6-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionOct 2011
- Study completionOct 2011
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 Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Stonell, FRCA MBBCh, Principal investigator, Imperial NHS Trust at St Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833508
- Sponsor's protocol ID
- 08/H0712/117
- Status last verified
- Feb 2016
- First submitted
- 30 Jan 2009
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Older P, Smith R, Courtney P, Hone R. Preoperative evaluation of cardiac failure and ischemia in elderly patients by cardiopulmonary exercise testing. Chest. 1993 Sep;104(3):701-4. doi: 10.1378/chest.104.3.701.
PubMed 8365279
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Chemoradiotherapy on Exercise Capacity as Measured by Cardiopulmonary Exercise Testing
- ClinicalTrials.gov ID
- NCT00833508
- Acronym / sponsor ID
- 08/H0712/117
- Conditions
- Colorectal Cancer
- Keywords
- Exercise capacity, Chemoradiotherapy, Colorectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 2 Feb 2009 (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 study will investigate the effect of preoperative chemoradiotherapy on exercise capacity as measured by cardiopulmonary exercise testing in patients with colorectal cancer.
Detailed description
Chemoradiotherapy is associated with adverse effects. Patients with certain colorectal cancers undergo chemoradiotherapy prior to surgical resection. We intend to assess patient exercise capacity before and after chemoradiotherapy to assess whether this deteriorates. If there is a deleterious effect, this may affect operative outcome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test arm | Experimental | Other: Cardiopulmonary exercise testingPatients undergoing preoperative chemoradiotherapy will have their exercise capacity measured before and after chemoradiotherapy. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age greater than 65
- Colorectal cancer requiring preoperative chemoradiotherapy
Key exclusion criteria (16 listed)
- Inability to walk, or exercise on a bicycle or treadmill
- Inability to understand instructions for CPET testing
- ASA grade 4 or 5 (indicating severe cardiovascular co-morbidity and not expected to survive surgery)
- Contraindications to Exercise Testing
- Myocardial infarction occurring 10 days or less before CPX testing
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 |
|---|---|---|
| Cardiopulmonary exercise testingCardiopulmonary exercise testing involves cycling on an exercise bicycle whilst oxygen consumption and carbon dioxide generation are measured from expired gases. This is used to calculate patient fitness from their peak oxygen consumption and their anaerobic threshold. | Other | Test arm |
Primary outcome
Change of Anaerobic threshold of 1.5ml/min/kg or more
Time frame: 6 weeks
1 secondary outcome
Operative outcome
Time frame: 6-10 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 17 Feb 2016.
- Background: PubMed 8365279Older P, Smith R, Courtney P, Hone R. Preoperative evaluation of cardiac failure and ischemia in elderly patients by cardiopulmonary exercise testing. Chest. 1993 Sep;104(3):701-4. doi: 10.1378/chest.104.3.701.
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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.
Christopher Stonell, FRCA MBBCh principal investigator
Imperial NHS Trust at St Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiopulmonary exercise testing in people with Colorectal Cancer, run by Imperial College London 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 2 inclusion and 16 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 17 Feb 2016. 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?
Change of Anaerobic threshold of 1.5ml/min/kg or more (time frame: 6 weeks). 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 NCT00833508, 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 17 Feb 2016.