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This is a prospective, longitudinal, controlled study of cognitive function and fatigue in patients with apparently localized CRC treated with adjuvant or neoadjuvant chemotherapy. In addition to following each patient over time (i.e. acting as their own control), a separate control group will consist of patients with early stage CRC (Stage A or B) who have had surgical resection of their tumour, but who do not require adjuvant chemotherapy, or patients with stage C CRC who have declined chemotherapy.
Also included is a smaller sub-study of patients with limited metastatic CRC who are treated with more toxic chemotherapy
To compare changes in cognitive function, as compared to baseline assessment, of patients with CRC who do, or do not, receive 5FU-based chemotherapy. The primary measures of cognitive function are the High Sensitivity Cognitive Screen (HSCS) & Coghealthâ„¢.
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| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Function | To compare changes in cognitive function, as compared to baseline assessment, of patients with CRC who do, or do not, receive 5FU-based chemotherapy. The primary measures of cognitive function are the High Sensitivity Cognitive Screen (HSCS) & Coghealthâ„¢. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Potential mechanisms leading to fatigue and/or cognitive decline | To evaluate potential mechanisms leading to fatigue and/or cognitive decline. To measure hemoglobin, serum levels of sex hormones (LH, FSH, estradiol (in women), testosterone (in men)), selected cytokines (TNF-α, IL-1 & IL-6), homocysteine, markers of blood coagulation (thrombin-anti-thrombin (TAT), prothrombin fragment 1 & 2, and d-dimers), and the apolipoprotein E genotype |
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Inclusion Criteria:
Exclusion Criteria:
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Patients being treated for Colorectal cancer at participating centres
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| Name | Affiliation | Role |
|---|---|---|
| Ian F Tannock, MD, PhD, DSc | UHN/PMH | Principal Investigator |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| 2 Years |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |