Cognitive Function and Fatigue in Cancer Patients After Chemotherapy: A Longitudinal Controlled Study in Patients With Colorectal Cancer
We will undertake a prospective, longitudinal controlled study of fatigue and cognitive
function in 120 patients with localized CRC who receive 5FU-based adjuvant chemotherapy.
Each patient will be evaluated at baseline and at 6, 12 and 24 months for fatigue (using the
FACT-F questionnaire) and for cognitive function, using validated tests: these will comprise
both traditional neuropsychological tests and the computerised CANTAB™, a which is less
dependent on fluency in English. Results during and after chemotherapy will be compared
with the pre-chemotherapy assessment (so that each patient acts as their own control).
Since baseline evaluation may be confounded by the recent diagnosis and surgery we will
include an independent control group of 120 patients who have undergone surgery for CRC but
who do not receive chemotherapy. Patients found to have cognitive change will be offered
further comprehensive neuropsychological assessment. We will also evaluate quality of life
(QOL) using the FACT-G questionnaire and anxiety and depression using the General Health
Questionnaire (GHQ). Blood tests including hormone levels, cytokines, homocysteine,
procoagulants and apo-lipoprotein E-є4 allele status will evaluate possible mechanisms.
Finally, since chemotherapy for CRC is evolving to include the more toxic drugs oxaliplatin
and irinotecan, we will perform a parallel pilot study evaluating pts with early recurrent
or metastatic CRC who receive these drugs, using similar methods of evaluation.
Observational
Time Perspective: Prospective
Janette Vardy, MD
Principal Investigator
Princess Margaret Hospital University of Toronto
Canada: Health Canada
COIT1
NCT00188331
November 2003
Name | Location |
---|