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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
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)

Study type
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
Comparator / control treatment
Control group


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
Both males and females
Can healthy volunteers participate?
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
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sydney Cancer Centre - Sydney
Recruitment postcode(s) [1] 0 0
2139 - Sydney
Recruitment outside Australia
Country [1] 0 0
State/province [1] 0 0

Funding & Sponsors
Primary sponsor type
University Health Network, Toronto
Other collaborator category [1] 0 0
Name [1] 0 0
Canadian Cancer Trials Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
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
Name [3] 0 0
Peterborough K.M. Hunter Graduate Studentship
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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
Trial related presentations / publications
Public notes

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

Summary results
Other publications