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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
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
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
Intervention code [1] 0 0
Behaviour
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00188331
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