Trial Review

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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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Cognitive Function and Fatigue in Cancer Patients After Chemotherapy: A Longitudinal Controlled Study in Patients With Colorectal Cancer
Secondary ID [1] 0 0
NCIC Grant No. #15261
Secondary ID [2] 0 0
COIT1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognition 0 0
Fatigue 0 0
Colorectal Neoplasm 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
BEHAVIORAL - Neuropsychological Testing

1 - adjuvant/neoadjuvant chemotherapy

2 - non-chemotherapy group

3 - limited metastatic disease or localised recurrence to receive first line metastatic chemotherapy


BEHAVIORAL: Neuropsychological Testing
neuropsychological testing with traditional tests, CANTAB and six elements test as well as questionnaires
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
441
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Cancer Centre - Sydney
Recruitment postcode(s) [1] 0 0
2139 - Sydney
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
University Health Network, Toronto
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Canadian Cancer Trials Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Young Investigator Award - American Society of Clinical Oncologists
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Peterborough K.M. Hunter Graduate Studentship
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janette Vardy, MD
Address 0 0
Princess Margaret Hospital University of Toronto
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00188331