NCT00833508

Brief Summary

This study will investigate the effect of preoperative chemoradiotherapy on exercise capacity as measured by cardiopulmonary exercise testing in patients with colorectal cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 2, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

2.7 years

First QC Date

January 30, 2009

Last Update Submit

February 15, 2016

Conditions

Colorectal Cancer

Keywords

Exercise capacityChemoradiotherapyColorectal cancer

Outcome Measures

Primary Outcomes (1)

  • Change of Anaerobic threshold of 1.5ml/min/kg or more

    6 weeks

Secondary Outcomes (1)

  • Operative outcome

    6-10 weeks

Study Arms (1)

Test arm

EXPERIMENTAL

Patients undergoing preoperative chemoradiotherapy will have their exercise capacity measured before and after chemoradiotherapy.

Other: Cardiopulmonary exercise testing

Interventions

Cardiopulmonary exercise testingOTHER

Cardiopulmonary exercise testing involves cycling on an exercise bicycle whilst oxygen consumption and carbon dioxide generation are measured from expired gases. This is used to calculate patient fitness from their peak oxygen consumption and their anaerobic threshold.

Test arm

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age greater than 65
  • Colorectal cancer requiring preoperative chemoradiotherapy

You may not qualify if:

  • Inability to walk, or exercise on a bicycle or treadmill
  • Inability to understand instructions for CPET testing
  • ASA grade 4 or 5 (indicating severe cardiovascular co-morbidity and not expected to survive surgery)
  • Contraindications to Exercise Testing
  • Myocardial infarction occurring 10 days or less before CPX testing
  • Symptomatic arrythmias
  • Left Main Stem coronary disease of \>50%
  • Severe hypertension (SBP\>180mmHg)
  • Resting SpO2 \<85%
  • Acute cardiac inflammatory conditions (myocarditis, pericarditis)
  • Unstable angina with symptoms within 4 days
  • Dissecting aneurysm of aorta
  • Acute pyrexial illness
  • Thyrotoxicosis
  • Syncopal episodes
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial NHS Trust, St Mary's Hospital, Praed Street

London, W2 1NY, United Kingdom

Location

Related Publications (1)

  • Older P, Smith R, Courtney P, Hone R. Preoperative evaluation of cardiac failure and ischemia in elderly patients by cardiopulmonary exercise testing. Chest. 1993 Sep;104(3):701-4. doi: 10.1378/chest.104.3.701.

    PMID: 8365279BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Christopher Stonell, FRCA MBBCh

    Imperial NHS Trust at St Mary's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2009

First Posted

February 2, 2009

Study Start

January 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

February 17, 2016

Record last verified: 2016-02

Locations

GB(1)