Status:
COMPLETED
A Longitudinal Investigation of Cognitive Function in Colorectal Cancer Patients
Lead Sponsor:
University Health Network, Toronto
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-70 years
Brief Summary
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 foll...
Eligibility Criteria
Inclusion
- Aged 18-70 years old
- Performance Status (PS) of 0-1 on the ECOG Performance Scale
- Life expectancy of at least 12 months
- Full recovery from any post operative sequelae
- Adequate hepatic function as documented by a serum bilirubin \< 18umol/L, and LFTs within 1.5X normal range
- Patients with histologically confirmed, stage B or C colorectal cancer (CRC), who have undergone surgical resection and are about to commence chemotherapy.
- Patients due to receive neoadjuvant chemotherapy prior to surgery are also eligible.
Exclusion
- 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. If there is clinical suspicion of 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
- 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.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01457287
Start Date
October 1 2003
Last Update
October 21 2011
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