Rectal CancerSRETPNCT01914068
The Effects of a 9 Week Exercise Programme on Fitness and Quality of Life in Rectal Cancer Patients After Chemoradiotherapy and Before Surgery
A study testing Supervised exercise in hospital in people with Rectal Cancer, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Patients' ability to tolerate surgery is associated with physical fitness: less fit patients have an increased rate of death and serious complications following major surgery. Combined chemotherapy and radiotherapy (x-rays) prior to rectal cancer surgery is known as neo-adjuvant chemoradiotherapy (NACRT) and is… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Supervised exercise in hospital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to Dec 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients listed to undergo elective rectal cancer resection and long course neoadjuvant chemoradiotherapy in the two NHS teaching hospitals (Aintree University Hospital NHS Foundation Trust and Southampton University Hospital NHS Foundation Trust)
Who cannot join
- Unable to consent.
- Under 18 years of age.
- Unable to perform exercise.
- Any contraindications on the American Thoracic Surgery CPET safety guidelines.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Investigate Improvements in Physical Fitness and Quality of Life Resulting From a 9 Week Structured Responsive Endurance Training Programme (SRETP) Following Neoadjuvant Chemoradiotherapy Prior to Elective Rectal Cancer Surgery
Patients' ability to tolerate surgery is associated with physical fitness: less fit patients have an increased rate of death and serious complications following major surgery. Combined chemotherapy and radiotherapy (x-rays) prior to rectal cancer surgery is known as neo-adjuvant chemoradiotherapy (NACRT) and is associated with improved cancer removal but adversely affects physical fitness. In Liverpool, the investigators have pre-pilot data showing that NACRT reduces objectively measured physical fitness (measured by cardiopulmonary exercise testing) in patients having surgery. This pre-pilot study investigated the effects of a 6-week structured responsive endurance training programme (SRETP) after NACRT and before cancer surgery. This programme has improved both their fitness and their health related quality of life(HRQL). Now, the investigators are undertaking a randomised controlled trial to compare changes in patient's physical fitness in response to SRETP with a group of patients who will be given exercise advice. The SRETP group will exercise 3 times a week for 9 weeks. The investigators will make objective measurements of physical fitness in both groups. The investigators will monitor patient's perceptions of the training programme, HRQL, daily activity (using an accelerometer), and outcomes after surgery. The investigators believe that, patients in the exercise group will improve their physical fitness prior to surgery, change behaviour towards exercise, improve activity and HRQL following NACRT. These results will contribute to the design of a large, multi-centre trial to determine whether a SRETP increases physical fitness with a reduction in adverse outcome following surgery. The investigators will conduct an adequately powered randomized controlled trial (RCT) comparing a SRETP with 'exercise advice' in 46 rectal cancer patients. Specifically, we will test the following hypotheses and outcomes: PRIMARY HYPOTHESIS A 9-week, structured responsive endurance training programme (SRETP) compared with a control group (no training) will result in a clinically significant difference in physical fitness (2.0ml/kg/min VO2 at LT) post-NACRT prior to surgery.
SECONDARY OUTCOMES
Read more
- A 9-week SRETP compared with a control group (no training) will result in a clinically significant difference in physical fitness (2.0ml/kg/min VO2Peak) in patients who have had NACRT prior to surgery.
- SRETP following NACRT and prior to cancer surgery will provide psychological health benefits and improve patient's HRQL (assessed by semi-structured interviews and questionnaires -EORTC QLQ-30 and EQ-5D). This will provide vital exploratory information that will inform a future application to deliver a larger appropriately powered RCT exploring the hypothesis that patients with greater pre-operative fitness will encounter lower postoperative morbidity and mortality. Specifically, these exploratory outcomes are:
EXPLORATORY OUTCOMES
- To investigate whether SRETP following NACRT and prior to surgery is associated with a change in overall physical activity (assessed by the number of steps while active using an accelerometer).
- To investigate whether there is a change in the day 7 surgical morbidity (using the Post-Operative Morbidity Survey) and mortality.
- The effect of SRETP on cancer downstaging post-NACRT (Tumour, Node and Metastasis Staging-TNM staging).
- Conditions
- Rectal Cancer
- Being tested
- Supervised exercise in hospital
- Keywords
- Neoadjuvant chemoradiotherapy (NACRT), Rectal cancer, Physical fitness, Exercise programme, Surgery, Stage III/IV, Locally advanced operable, patients
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exercise in hospitalOther
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No in hospital exercise training and no exercise advice. |
| Exercise Intervention | Active comparator | In hospital exercise training Receives: Other: Supervised exercise in hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical fitness measured by CPET (ml/kg/min)
Cardiopulmonary exercise tests will be performed at the time points specified
Measured: Pre neoadjuvant chemoradiotherpy(NACRT), post NACRT (week 0 of SRETP) and week 9 of SRETP
Secondary outcomes (2)
Quality of life
Health related quality of life questionnaires will be filled out at each specified time point
Measured: Pre NACRT (baseline), Mid NACRT (during treatment week3 to 6 dependent on local policies), week 3,9 of SRETP
Physical activity
Physical activity monitors, like an armband, will be worn at each specified time point for three days at a time
Measured: Pre NACRT(baseline), Mid NACRT(during treatment 3 to 6 weeks dependent on local policies), week3, 9 of SRETP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectal 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- AintreeNHSTrust
- Responsible party
- Sponsor
- Investigators
- Sandy Jack, MSc, PhD, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914068
- Sponsor's protocol ID
- PB-PG-0711-25093
- Other IDs
- PB-PG-0711-25093
- Acronym
- SRETP
- Status last verified
- Oct 2016
- First submitted
- 7 Jun 2013
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Loughney L, West MA, Moyses H, Bates A, Kemp GJ, Hawkins L, Varkonyi-Sepp J, Burke S, Barben CP, Calverley PM, Cox T, Palmer DH, Mythen MG, Grocott MPW, Jack S; Fit4Surgery group. The effects of neoadjuvant chemoradiotherapy and an in-hospital exercise training programme on physical fitness and quality of life in locally advanced rectal cancer patients: a randomised controlled trial (The EMPOWER Trial). Perioper Med (Lond). 2021 Jun 22;10(1):23. doi: 10.1186/s13741-021-00190-8.
PubMed 34154675Loughney L, West MA, Kemp GJ, Rossiter HB, Burke SM, Cox T, Barben CP, Mythen MG, Calverley P, Palmer DH, Grocott MP, Jack S. The effects of neoadjuvant chemoradiotherapy and an in-hospital exercise training programme on physical fitness and quality of life in locally advanced rectal cancer patients (The EMPOWER Trial): study protocol for a randomised controlled trial. Trials. 2016 Jan 13;17:24. doi: 10.1186/s13063-015-1149-4.
PubMed 26762365
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate Improvements in Physical Fitness and Quality of Life Resulting From a 9 Week Structured Responsive Endurance Training Programme (SRETP) Following Neoadjuvant Chemoradiotherapy Prior to Elective Rectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT01914068
- Acronym / sponsor ID
- SRETP / PB-PG-0711-25093
- Conditions
- Rectal Cancer
- Keywords
- Neoadjuvant chemoradiotherapy (NACRT), Rectal cancer, Physical fitness, Exercise programme, Surgery, Stage III/IV, Locally advanced operable, patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- AintreeNHSTrust
- Study start
- Aug 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Aug 2013 (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.
Patients' ability to tolerate surgery is associated with physical fitness: less fit patients have an increased rate of death and serious complications following major surgery. Combined chemotherapy and radiotherapy (x-rays) prior to rectal cancer surgery is known as neo-adjuvant chemoradiotherapy (NACRT) and is associated with improved cancer removal but adversely affects physical fitness. In Liverpool, the investigators have pre-pilot data showing that NACRT reduces objectively measured physical fitness (measured by cardiopulmonary exercise testing) in patients having surgery. This pre-pilot study investigated the effects of a 6-week structured responsive endurance training programme (SRETP) after NACRT and before cancer surgery. This programme has improved both their fitness and their health related quality of life(HRQL). Now, the investigators are undertaking a randomised controlled trial to compare changes in patient's physical fitness in response to SRETP with a group of patients who will be given exercise advice. The SRETP group will exercise 3 times a week for 9 weeks. The investigators will make objective measurements of physical fitness in both groups. The investigators will monitor patient's perceptions of the training programme, HRQL, daily activity (using an accelerometer), and outcomes after surgery. The investigators believe that, patients in the exercise group will improve their physical fitness prior to surgery, change behaviour towards exercise, improve activity and HRQL following NACRT. These results will contribute to the design of a large, multi-centre trial to determine whether a SRETP increases physical fitness with a reduction in adverse outcome following surgery. The investigators will conduct an adequately powered randomized controlled trial (RCT) comparing a SRETP with 'exercise advice' in 46 rectal cancer patients. Specifically, we will test the following hypotheses and outcomes: PRIMARY HYPOTHESIS A 9-week, structured responsive endurance training programme (SRETP) compared with a control group (no training) will result in a clinically significant difference in physical fitness (2.0ml/kg/min VO2 at LT) post-NACRT prior to surgery.
SECONDARY OUTCOMES
- A 9-week SRETP compared with a control group (no training) will result in a clinically significant difference in physical fitness (2.0ml/kg/min VO2Peak) in patients who have had NACRT prior to surgery.
- SRETP following NACRT and prior to cancer surgery will provide psychological health benefits and improve patient's HRQL (assessed by semi-structured interviews and questionnaires -EORTC QLQ-30 and EQ-5D). This will provide vital exploratory information that will inform a future application to deliver a larger appropriately powered RCT exploring the hypothesis that patients with greater pre-operative fitness will encounter lower postoperative morbidity and mortality. Specifically, these exploratory outcomes are:
EXPLORATORY OUTCOMES
- To investigate whether SRETP following NACRT and prior to surgery is associated with a change in overall physical activity (assessed by the number of steps while active using an accelerometer).
- To investigate whether there is a change in the day 7 surgical morbidity (using the Post-Operative Morbidity Survey) and mortality.
- The effect of SRETP on cancer downstaging post-NACRT (Tumour, Node and Metastasis Staging-TNM staging).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No in hospital exercise training and no exercise advice. |
| Exercise Intervention | Active comparator | Other: Supervised exercise in hospitalIn hospital exercise training |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients listed to undergo elective rectal cancer resection and long course neoadjuvant chemoradiotherapy in the two NHS teaching hospitals (Aintree University Hospital NHS Foundation Trust and Southampton University Hospital NHS Foundation Trust)
Key exclusion criteria (4 listed)
- Unable to consent.
- Under 18 years of age.
- Unable to perform exercise.
- Any contraindications on the American Thoracic Surgery CPET safety guidelines.
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 |
|---|---|---|
| Supervised exercise in hospital | Other | Exercise Intervention |
Primary outcome
Change in physical fitness measured by CPET (ml/kg/min)
Time frame: Pre neoadjuvant chemoradiotherpy(NACRT), post NACRT (week 0 of SRETP) and week 9 of SRETP
Cardiopulmonary exercise tests will be performed at the time points specified
2 secondary outcomes
Quality of life
Time frame: Pre NACRT (baseline), Mid NACRT (during treatment week3 to 6 dependent on local policies), week 3,9 of SRETP
Physical activity
Time frame: Pre NACRT(baseline), Mid NACRT(during treatment 3 to 6 weeks dependent on local policies), week3, 9 of SRETP
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 Oct 2016.
- Derived from this study: PubMed 34154675Loughney L, West MA, Moyses H, Bates A, Kemp GJ, Hawkins L, Varkonyi-Sepp J, Burke S, Barben CP, Calverley PM, Cox T, Palmer DH, Mythen MG, Grocott MPW, Jack S; Fit4Surgery group. The effects of neoadjuvant chemoradiotherapy and an in-hospital exercise training programme on physical fitness and quality of life in locally advanced rectal cancer patients: a randomised controlled trial (The EMPOWER Trial). Perioper Med (Lond). 2021 Jun 22;10(1):23. doi: 10.1186/s13741-021-00190-8.
- Derived from this study: PubMed 26762365Loughney L, West MA, Kemp GJ, Rossiter HB, Burke SM, Cox T, Barben CP, Mythen MG, Calverley P, Palmer DH, Grocott MP, Jack S. The effects of neoadjuvant chemoradiotherapy and an in-hospital exercise training programme on physical fitness and quality of life in locally advanced rectal cancer patients (The EMPOWER Trial): study protocol for a randomised controlled trial. Trials. 2016 Jan 13;17:24. doi: 10.1186/s13063-015-1149-4.
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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.
Sandy Jack, MSc, PhD principal investigator
University Hospital Southampton NHS Foundation 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 Supervised exercise in hospital in people with Rectal Cancer, run by University Hospital Southampton NHS Foundation 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 4 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 Oct 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 in physical fitness measured by CPET (ml/kg/min) (time frame: Pre neoadjuvant chemoradiotherpy(NACRT), post NACRT (week 0 of SRETP) and week 9 of SRETP). 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 NCT01914068, which also lists 2 linked publications.
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 Oct 2016.