Exercise Training in Colorectal Cancer Patients

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325909
• Other study ID #: 11/H1002/12
• Status: Completed
• Phase: N/A
• First received: March 29, 2011
• Last updated: April 4, 2014
• Start date: March 2011
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Aintree University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Rectal Cancer

Intervention

Behavioral:
• Exercise programme

Locations

Country	Name	City	State
United Kingdom	Aintree University Hospitals	Liverpool

Sponsors (2)

Lead Sponsor	Collaborator
Michelle Mossa	University Hospital Southampton NHS Foundation Trust.

Country where clinical trial is conducted

United Kingdom, 

Outcome

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