Exercise Training in Colorectal Cancer Patients

Michelle Mossa

Status: Completed

Conditions: Rectal Cancer

Treatments: Behavioral: Exercise programme

Study type: Interventional

Funder types: Other

Identifiers

NCT01325909

11/H1002/12

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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35 participants in 2 patient groups

Exercise

Active Comparator group

Treatment:

Behavioral: Exercise programme

No Exercise

No Intervention group