Status:
COMPLETED
Cognitive Function and Fatigue in Colorectal Cancer (CRC) Patients After Chemotherapy
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Canadian Cancer Trials Group
Young Investigator Award - American Society of Clinical Oncologists
Conditions:
Cognition
Fatigue
Eligibility:
All Genders
18-75 years
Brief 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...
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 ev...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
441 Patients enrolled
Trial Details
Trial ID
NCT00188331
Start Date
November 1 2003
End Date
September 1 2015
Last Update
March 22 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Sydney Cancer Centre
Sydney, New South Wales, Australia, 2139
2
University Health Network
Toronto, Ontario, Canada, M5G 2M9