Rectal Cancer Clinical Trial
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:
1. Is exercise intervention feasible and tolerable in this cohort of patients?
2. Can fitness be improved using a structured, responsive exercise training programme
(SRETP)?
3. Can SRETP improve quality of life?
4. Can SRETP improve physical activity?
5. Can SRETP improve surgical outcome?
6. 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.
Status | Completed |
Enrollment | 35 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All patients listed to undergo elective colorectal cancer resection and longcourse neoadjuvant chemoradiotherapy at Aintree University Hospitals NHS Foundation Trust Exclusion Criteria: - Unable to consent - Under 18 years of age - Unable to perform exercise - Meet any contraindications on the ATS CPET safety guidelines |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Aintree University Hospitals | Liverpool |
Lead Sponsor | Collaborator |
---|---|
Michelle Mossa | University Hospital Southampton NHS Foundation Trust. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients. | 3 years | No | |
Secondary | Other measures of physical fitness measured in CPET or the VO2 kinetics test | 3 years | No | |
Secondary | Adherence to a 6 week interval exercise intervention. | 3 years | No | |
Secondary | Optimal time for surgery indicating optimal oncological and physiological fitness | 3 years | No | |
Secondary | Health related quality of life improvement as measured by SF36, EORCT c30 v3 | 3 years | No | |
Secondary | Outcome from major surgery measured by 5 day POMS | 3 years | No | |
Secondary | Activity levels before during and after neoadjuvant chemoradiotherapy | 3 years | No |
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