NCT00188331

Cognitive Function and Fatigue in Colorectal Cancer (CRC) Patients After Chemotherapy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 441 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Cognition
• Fatigue
• Colorectal Neoplasm

Interventions

Type	Name	Description
BEHAVIORAL	Neuropsychological Testing	neuropsychological testing with traditional tests, CANTAB and six elements test as well as questionnaires

Timeline

• Start date: 2003-11-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2005-09-16
• Last updated: 2016-03-22

Locations

2 sites across 2 countries: Australia, Canada