Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00188331
Registration number
NCT00188331
Ethics application status
Date submitted
9/09/2005
Date registered
16/09/2005
Date last updated
22/03/2016
Titles & IDs
Public title
Cognitive Function and Fatigue in Colorectal Cancer (CRC) Patients After Chemotherapy
Query!
Scientific title
Cognitive Function and Fatigue in Cancer Patients After Chemotherapy: A Longitudinal Controlled Study in Patients With Colorectal Cancer
Query!
Secondary ID [1]
0
0
NCIC Grant No. #15261
Query!
Secondary ID [2]
0
0
COIT1
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cognition
0
0
Query!
Fatigue
0
0
Query!
Colorectal Neoplasm
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Bowel - Back passage (rectum) or large bowel (colon)
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Behaviour - Neuropsychological Testing
1 - adjuvant/neoadjuvant chemotherapy
2 - non-chemotherapy group
3 - limited metastatic disease or localised recurrence to receive first line metastatic chemotherapy
Behaviour: Neuropsychological Testing
neuropsychological testing with traditional tests, CANTAB and six elements test as well as questionnaires
Query!
Intervention code [1]
0
0
Behaviour
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Eligibility
Key inclusion criteria
- Histologically confirmed colorectal cancer
- Age 18-75
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy of at least 12 months
- Full recovery from any post operative sequelae
- Adequate hepatic function as documented by a serum bilirubin < 18 umol/L, and liver
function tests (LFTs) within 1.5X normal range
- Informed consent
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Any major pre-existing psychiatric history or dementia, alcohol abuse, or currently
using a psychotropic medication that might lead to cognitive problems, other than
short acting benzodiazepines for nausea or sleep
- Any evidence of metastatic disease other than group C who may have limited metastatic
disease. If there is clinical suspicion of central nervous system (CNS) involvement
patients must have brain imaging (MRI or CT scan) prior to recruitment.
- Ongoing sepsis or uncontrolled infection, including HIV infection
- Pre-existing neurological condition likely to interfere with ability to perform
cognitive testing
- Any other severe co-morbidity which, in the judgement of the investigator, would make
the patient inappropriate for entry into this study
- Active cancer within the last 5 years other than squamous or basal cell carcinoma of
the skin or cervical cancer in situ (except for CRC)
- Previous history of chemotherapy, other than adjuvant chemotherapy for group C
metastatic group > 1 year previously
- Minimal English skills such that subjects would be unable to follow simple, written
English instructions and to read questionnaires of a grade 8 standard with the help of
a research assistant.
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/11/2003
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/09/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
441
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Sydney Cancer Centre - Sydney
Query!
Recruitment postcode(s) [1]
0
0
2139 - Sydney
Query!
Recruitment outside Australia
Country [1]
0
0
Canada
Query!
State/province [1]
0
0
Ontario
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
University Health Network, Toronto
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Canadian Cancer Trials Group
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
Young Investigator Award - American Society of Clinical Oncologists
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Other
Query!
Name [3]
0
0
Peterborough K.M. Hunter Graduate Studentship
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a prospective, longitudinal cohort study to evaluate fatigue and cognitive function
in patients with colorectal cancer (CRC) treated with chemotherapy, and in patients with the
same malignancy, that do not receive chemotherapy. A self-report questionnaire for fatigue
(the FACT-F), and validated tests of cognitive function, will be applied at predetermined
times before, during and after chemotherapy, to determine the incidence, severity and
duration of these symptoms. Comparisons will be made in changes in cognition for individuals,
as well as between the chemotherapy and the control group. Mechanisms that might lead to
fatigue and/or cognitive decline will be investigated.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00188331
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Janette Vardy, MD
Query!
Address
0
0
Princess Margaret Hospital University of Toronto
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00188331
Download to PDF