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Cognitive Function and Fatigue in Cancer Patients After Chemotherapy: A Longitudinal Controlled Study in Patients With Colorectal Cancer

18 Years
75 Years
Open (Enrolling)
Cognition, Fatigue, Colorectal Neoplasm

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Trial Information

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.

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

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.

Type of Study:


Study Design:

Time Perspective: Prospective

Principal Investigator

Janette Vardy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital University of Toronto


Canada: Health Canada

Study ID:




Start Date:

November 2003

Completion Date:

Related Keywords:

  • Cognition
  • Fatigue
  • Colorectal Neoplasm
  • cognitive function
  • fatigue
  • colorectal cancer
  • chemotherapy
  • cognitive impairment
  • Neoplasms
  • Colorectal Neoplasms
  • Fatigue