Exercise Training in Colorectal Cancer Patients | NCT01325909

Studies
Exercise Training in Colorectal Cancer Patients

NCT01325909

Sponsor

Michelle Mossa

Status

Completed

Last Update Posted

Apr 7, 2014Estimated

Enrollment

35Estimated

Phase

Not Applicable

Conditions

Rectal Cancer

Interventions

Exercise programme

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Mar 29, 2011

First Submission Date that Met QC Criteria

Mar 29, 2011

First Posted Date

Mar 30, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2014

Last Update Posted Date

Apr 7, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michelle Mossa, Research and Development Director, Liverpool University Hospitals NHS Foundation TrustSponsor-Investigator

Lead Sponsor

Michelle MossaOTHER_GOV

Collaborators

Name	Class
University Hospital Southampton NHS Foundation Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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:

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise	Active Comparator		Behavioral: Exercise programme
No Exercise	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise programme	Behavioral		Exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients.		3 years

Secondary Outcomes

Measure	Description	Time Frame
Other measures of physical fitness measured in CPET or the VO2 kinetics test		3 years
Adherence to a 6 week interval exercise intervention.		3 years
Optimal time for surgery indicating optimal oncological and physiological fitness

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Malcolm A West, MD MRCS	Aintree University Hospitals NHS Foundation Trust, Liverpool, UK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aintree University Hospitals		Liverpool		L9 7AL	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28228938	Derived	Loughney L, West MA, Dimitrov BD, Kemp GJ, Grocott MP, Jack S. Physical activity levels in locally advanced rectal cancer patients following neoadjuvant chemoradiotherapy and an exercise training programme before surgery: a pilot study. Perioper Med (Lond). 2017 Feb 16;6:3. doi: 10.1186/s13741-017-0058-3. eCollection 2017.
28228123

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms