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Completed

NCT Number: NCT01325909

Exercise Training 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aintree University Hospitals

Liverpool, L9 7AL, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Programme

Behavioral

Primary outcomes

  1. Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients.

    Time frame: 3 years

Secondary outcomes

  1. Other measures of physical fitness measured in CPET or the VO2 kinetics test

    Time frame: 3 years

  2. Adherence to a 6 week interval exercise intervention.

    Time frame: 3 years

  3. Optimal time for surgery indicating optimal oncological and physiological fitness

    Time frame: 3 years

  4. Health related quality of life improvement as measured by SF36, EORCT c30 v3

    Time frame: 3 years

  5. Outcome from major surgery measured by 5 day POMS

    Time frame: 3 years

  6. Activity levels before during and after neoadjuvant chemoradiotherapy

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Michelle Mossa

Other Gov

Collaborators

  • University Hospital Southampton NHS Foundation Trust

Registry information

Official study title

Does Short-term Exercise Intervention Improve Pre-operative Physical Fitness Following Neoadjuvant Chemoradiotherapy in Colorectal Cancer Patients?

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 30, 2011
Registry last updated
Apr 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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