NCT00470782

Brief Summary

Recent studies have shown that survival after a colorectal cancer diagnosis may be affected by a person's activity level and body size. This research says that for colorectal cancer patients, the less active and more obese they are, the more likely they are to have a cancer recurrence or die from their cancer. Chemotherapy has been shown to reduce activity levels, fitness, and body size in some cancer patients. However, it is not known how chemotherapy specific for colon cancer patients affects their activity levels, fitness, and body size. The main goal of our study will be to look at how chemotherapy treatments affect the fitness, activity levels, and body size in colon cancer patients. In order to do this, we will measure these variables before chemotherapy treatments, and at 1 and 6 months following the end of treatment. Our results will show how chemotherapy affects fitness, activity levels, and body size in colon cancer patients and provide data to help in designing an exercise intervention specifically for colon cancer survivors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2007

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

First Submitted

Initial submission to the registry

May 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

February 26, 2016

Status Verified

April 1, 2012

Enrollment Period

2 years

First QC Date

May 7, 2007

Last Update Submit

February 24, 2016

Conditions

Keywords

colonic neoplasmsexercisebody compositionanthropometry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • histologically confirmed colon cancer (Stage III and those Stage II patients deemed high-risk
  • approval of the treating oncologist
  • scheduled to received chemotherapy
  • able to understand and provide written informed consent in English
  • + years of age
  • no uncontrolled co-morbidities (including hypertension, cardiac illness, psychiatric condition, etc.)
  • negative ECG as assessed during maximal graded exercise test

You may not qualify if:

  • metastatic or recurrent colon cancer patients
  • pregnancy
  • any uncontrolled medical condition that would be a contraindication to exercise (assessed by treating oncologist)
  • unwilling to attend, travel to or participate in the assessments at all 3 time points
  • In addition, 10 patients meeting all of the eligibility criteria who are not scheduled to receive chemotherapy will also be recruited to the study to serve as "surgery only" controls.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Colonic NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesBehavior

Study Officials

  • Kerry Courneya, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2007

First Posted

May 8, 2007

Study Start

October 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

February 26, 2016

Record last verified: 2012-04

Locations