Rectal CancerNCT01325909
Exercise Training in Colorectal Cancer Patients
A study testing Exercise programme in people with Rectal Cancer, run by Michelle Mossa at 1 site in United Kingdom.
Trial summary
Neoadjuvant chemoradiotherapy (NACRT) prior to surgery for lower gastrointestinal (colon and rectal) cancer is associated with improved survival, but also adversely affects physical fitness, potentially rendering patients unfit for major surgery or increasing the risk of adverse outcome (death and serious… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Exercise programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to Apr 2014
- 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
- All patients listed to undergo elective colorectal cancer resection and longcourse neoadjuvant chemoradiotherapy at Aintree University Hospitals NHS Foundation Trust
Who cannot join
- Unable to consent
- Under 18 years of age
- Unable to perform exercise
- Meet any contraindications on the ATS CPET safety guidelines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Short-term Exercise Intervention Improve Pre-operative Physical Fitness Following Neoadjuvant Chemoradiotherapy in Colorectal Cancer Patients?
Neoadjuvant chemoradiotherapy (NACRT) prior to surgery for lower gastrointestinal (colon and rectal) cancer is associated with improved survival, but also adversely affects physical fitness, potentially rendering patients unfit for major surgery or increasing the risk of adverse outcome (death and serious complications) after major surgery. The investigators have pilot data using an upper gastrointestinal cancer patient cohort showing that neoadjuvant chemotherapy (NAC)reduces objectively measured exercise capacity (fitness). The investigators therefore propose a blinded, single centre, prospective interventional trial of patients undergoing NACRT prior to elective colorectal cancer resection in an NHS teaching hospital.
The investigators wish to explore various hypotheses:
Read more
- Is exercise intervention feasible and tolerable in this cohort of patients?
- Can fitness be improved using a structured, responsive exercise training programme (SRETP)?
- Can SRETP improve quality of life?
- Can SRETP improve physical activity?
- Can SRETP improve surgical outcome?
- Can physiological fitness and oncological outcome be matched to identify an optimal time for physiological recovery following NACRT prior to major surgery.
The investigators aim to recruit 5 patients for a feasibility and tolerably study and 30 patients for an interventional study over 24 months from Aintree University Teaching Hospitals NHS Foundation Trust. Consenting patients will undergo a series of tests designed to evaluate the ability of the muscle to take up and utilise oxygen, namely a cardiopulmonary exercise test (CPET) and VO2 Kinetics tests, all done pre-CRT and at 3,6,9 and 14 weeks post-CRT (pre-surgery). All patients will have their CPET, as well as standard restaging scans at 9 and 14 weeks post NACRT. Outcome, activity and quality of life data will also be collected.
- Conditions
- Rectal Cancer
- Being tested
- Exercise programme
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programmeBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Active comparator | Not described Receives: Behavioral: Exercise programme |
| No Exercise | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients.
Measured: 3 years
Secondary outcomes (6)
Other measures of physical fitness measured in CPET or the VO2 kinetics test
Measured: 3 years
Adherence to a 6 week interval exercise intervention.
Measured: 3 years
Optimal time for surgery indicating optimal oncological and physiological fitness
Measured: 3 years
Health related quality of life improvement as measured by SF36, EORCT c30 v3
Measured: 3 years
Outcome from major surgery measured by 5 day POMS
Measured: 3 years
Activity levels before during and after neoadjuvant chemoradiotherapy
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michelle Mossa
- Sponsor type
- Other government
- Collaborators
- University Hospital Southampton NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Michelle Mossa, Liverpool University Hospitals NHS Foundation Trust
- Investigators
- Malcolm A West, MD MRCS, Principal investigator, Aintree University Hospitals NHS Foundation Trust, Liverpool, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325909
- Sponsor's protocol ID
- 11/H1002/12
- Status last verified
- Apr 2014
- First submitted
- 29 Mar 2011
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Loughney L, West MA, Dimitrov BD, Kemp GJ, Grocott MP, Jack S. Physical activity levels in locally advanced rectal cancer patients following neoadjuvant chemoradiotherapy and an exercise training programme before surgery: a pilot study. Perioper Med (Lond). 2017 Feb 16;6:3. doi: 10.1186/s13741-017-0058-3. eCollection 2017.
PubMed 28228938Brunet J, Burke S, Grocott MP, West MA, Jack S. The effects of exercise on pain, fatigue, insomnia, and health perceptions in patients with operable advanced stage rectal cancer prior to surgery: a pilot trial. BMC Cancer. 2017 Feb 23;17(1):153. doi: 10.1186/s12885-017-3130-y.
PubMed 28228123West MA, Dimitrov BD, Moyses HE, Kemp GJ, Loughney L, White D, Grocott MP, Jack S, Brown G. Timing of surgery following neoadjuvant chemoradiotherapy in locally advanced rectal cancer - A comparison of magnetic resonance imaging at two time points and histopathological responses. Eur J Surg Oncol. 2016 Sep;42(9):1350-8. doi: 10.1016/j.ejso.2016.04.003. Epub 2016 Apr 26.
PubMed 27160356West MA, Loughney L, Lythgoe D, Barben CP, Sripadam R, Kemp GJ, Grocott MP, Jack S. Effect of prehabilitation on objectively measured physical fitness after neoadjuvant treatment in preoperative rectal cancer patients: a blinded interventional pilot study. Br J Anaesth. 2015 Feb;114(2):244-51. doi: 10.1093/bja/aeu318. Epub 2014 Oct 1.
PubMed 25274049
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Short-term Exercise Intervention Improve Pre-operative Physical Fitness Following Neoadjuvant Chemoradiotherapy in Colorectal Cancer Patients?
- ClinicalTrials.gov ID
- NCT01325909
- Acronym / sponsor ID
- 11/H1002/12
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Michelle MossaOther government
- Collaborators
- University Hospital Southampton NHS Foundation Trust
- Study start
- Mar 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 30 Mar 2011 (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.
Neoadjuvant chemoradiotherapy (NACRT) prior to surgery for lower gastrointestinal (colon and rectal) cancer is associated with improved survival, but also adversely affects physical fitness, potentially rendering patients unfit for major surgery or increasing the risk of adverse outcome (death and serious complications) after major surgery. The investigators have pilot data using an upper gastrointestinal cancer patient cohort showing that neoadjuvant chemotherapy (NAC)reduces objectively measured exercise capacity (fitness). The investigators therefore propose a blinded, single centre, prospective interventional trial of patients undergoing NACRT prior to elective colorectal cancer resection in an NHS teaching hospital.
The investigators wish to explore various hypotheses:
- Is exercise intervention feasible and tolerable in this cohort of patients?
- Can fitness be improved using a structured, responsive exercise training programme (SRETP)?
- Can SRETP improve quality of life?
- Can SRETP improve physical activity?
- Can SRETP improve surgical outcome?
- Can physiological fitness and oncological outcome be matched to identify an optimal time for physiological recovery following NACRT prior to major surgery.
The investigators aim to recruit 5 patients for a feasibility and tolerably study and 30 patients for an interventional study over 24 months from Aintree University Teaching Hospitals NHS Foundation Trust. Consenting patients will undergo a series of tests designed to evaluate the ability of the muscle to take up and utilise oxygen, namely a cardiopulmonary exercise test (CPET) and VO2 Kinetics tests, all done pre-CRT and at 3,6,9 and 14 weeks post-CRT (pre-surgery). All patients will have their CPET, as well as standard restaging scans at 9 and 14 weeks post NACRT. Outcome, activity and quality of life data will also be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Behavioral: Exercise programme |
| No Exercise | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients listed to undergo elective colorectal cancer resection and longcourse neoadjuvant chemoradiotherapy at Aintree University Hospitals NHS Foundation Trust
Key exclusion criteria (4 listed)
- Unable to consent
- Under 18 years of age
- Unable to perform exercise
- Meet any contraindications on the ATS 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 |
|---|---|---|
| Exercise programme | Behavioural | Exercise |
Primary outcome
Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients.
Time frame: 3 years
6 secondary outcomes
Other measures of physical fitness measured in CPET or the VO2 kinetics test
Time frame: 3 years
Adherence to a 6 week interval exercise intervention.
Time frame: 3 years
Optimal time for surgery indicating optimal oncological and physiological fitness
Time frame: 3 years
Health related quality of life improvement as measured by SF36, EORCT c30 v3
Time frame: 3 years
Outcome from major surgery measured by 5 day POMS
Time frame: 3 years
Activity levels before during and after neoadjuvant chemoradiotherapy
Time frame: 3 years
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 7 Apr 2014.
- Derived from this study: PubMed 28228938Loughney L, West MA, Dimitrov BD, Kemp GJ, Grocott MP, Jack S. Physical activity levels in locally advanced rectal cancer patients following neoadjuvant chemoradiotherapy and an exercise training programme before surgery: a pilot study. Perioper Med (Lond). 2017 Feb 16;6:3. doi: 10.1186/s13741-017-0058-3. eCollection 2017.
- Derived from this study: PubMed 28228123Brunet J, Burke S, Grocott MP, West MA, Jack S. The effects of exercise on pain, fatigue, insomnia, and health perceptions in patients with operable advanced stage rectal cancer prior to surgery: a pilot trial. BMC Cancer. 2017 Feb 23;17(1):153. doi: 10.1186/s12885-017-3130-y.
- Derived from this study: PubMed 27160356West MA, Dimitrov BD, Moyses HE, Kemp GJ, Loughney L, White D, Grocott MP, Jack S, Brown G. Timing of surgery following neoadjuvant chemoradiotherapy in locally advanced rectal cancer - A comparison of magnetic resonance imaging at two time points and histopathological responses. Eur J Surg Oncol. 2016 Sep;42(9):1350-8. doi: 10.1016/j.ejso.2016.04.003. Epub 2016 Apr 26.
- Derived from this study: PubMed 25274049West MA, Loughney L, Lythgoe D, Barben CP, Sripadam R, Kemp GJ, Grocott MP, Jack S. Effect of prehabilitation on objectively measured physical fitness after neoadjuvant treatment in preoperative rectal cancer patients: a blinded interventional pilot study. Br J Anaesth. 2015 Feb;114(2):244-51. doi: 10.1093/bja/aeu318. Epub 2014 Oct 1.
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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.
Malcolm A West, MD MRCS principal investigator
Aintree University Hospitals NHS Foundation Trust, Liverpool, UK
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 programme in people with Rectal Cancer, run by Michelle Mossa 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 7 Apr 2014. 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?
Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients. (time frame: 3 years). 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 NCT01325909, which also lists 4 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 7 Apr 2014; AzTrials last refreshed its copy on 1 Nov 2026.