Exercise Training in Colorectal Cancer Patients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Rectal Cancer |
Behavioral: Exercise programme |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Does Short-term Exercise Intervention Improve Pre-operative Physical Fitness Following Neoadjuvant Chemoradiotherapy in Colorectal Cancer Patients? |
- Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Other measures of physical fitness measured in CPET or the VO2 kinetics test [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Adherence to a 6 week interval exercise intervention. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Optimal time for surgery indicating optimal oncological and physiological fitness [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Health related quality of life improvement as measured by SF36, EORCT c30 v3 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Outcome from major surgery measured by 5 day POMS [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Activity levels before during and after neoadjuvant chemoradiotherapy [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 35 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Exercise | Behavioral: Exercise programme |
| No Intervention: No Exercise |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Malcolm West | 447779159952 | malcolmwest@nhs.net |
| United Kingdom | |
| Aintree University Hospitals | Recruiting |
| Liverpool, United Kingdom, L9 7AL | |
| Contact: Malcolm West 447779159952 malcolmwest@nhs.net | |
| Principal Investigator: Malcolm A West, MD MRCS(Ed) | |
| Principal Investigator: | Malcolm A West, MD MRCS | Aintree University Hospitals NHS Foundation Trust, Liverpool, UK |
More Information
No publications provided
| Responsible Party: | Michelle Mossa, Research and Development Director, Aintree University Hospitals NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01325909 History of Changes |
| Other Study ID Numbers: | 11/H1002/12 |
| Study First Received: | March 29, 2011 |
| Last Updated: | December 29, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Colonic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013