Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188331
Status:
COMPLETED
Last Update Posted:
2016-03-22
First Post:
2005-09-09
Brief Title:
Cognitive Function and Fatigue in Colorectal Cancer CRC Patients After Chemotherapy
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Cognitive Function and Fatigue in Cancer Patients After Chemotherapy A Longitudinal Controlled Study in Patients With Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCIC Grant No 15261 | None | None | None |