Cognitive Function and Fatigue in Colorectal Cancer (CRC) Patients After Chemotherapy
2 other identifiers
observational
441
2 countries
2
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 and/or cognitive decline will be investigated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2003
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedMarch 22, 2016
March 1, 2016
11.8 years
September 9, 2005
March 21, 2016
Conditions
Keywords
Study Arms (3)
1
adjuvant/neoadjuvant chemotherapy
2
non-chemotherapy group
3
limited metastatic disease or localised recurrence to receive first line metastatic chemotherapy
Interventions
neuropsychological testing with traditional tests, CANTAB and six elements test as well as questionnaires
Eligibility Criteria
colorectal cancer patients aged 18-75
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sydney Cancer Centre
Sydney, New South Wales, 2139, Australia
University Health Network
Toronto, Ontario, M5G 2M9, Canada
Related Publications (4)
Vardy JL, Dhillon HM, Pond GR, Renton C, Clarke SJ, Tannock IF. Prognostic indices of inflammatory markers, cognitive function and fatigue for survival in patients with localised colorectal cancer. ESMO Open. 2018 Feb 14;3(2):e000302. doi: 10.1136/esmoopen-2017-000302. eCollection 2018.
PMID: 29531839DERIVEDDhillon HM, Tannock IF, Pond GR, Renton C, Rourke SB, Vardy JL. Perceived cognitive impairment in people with colorectal cancer who do and do not receive chemotherapy. J Cancer Surviv. 2018 Apr;12(2):178-185. doi: 10.1007/s11764-017-0656-6. Epub 2017 Oct 27.
PMID: 29080061DERIVEDVardy JL, Dhillon HM, Pond GR, Renton C, Dodd A, Zhang H, Clarke SJ, Tannock IF. Fatigue in people with localized colorectal cancer who do and do not receive chemotherapy: a longitudinal prospective study. Ann Oncol. 2016 Sep;27(9):1761-7. doi: 10.1093/annonc/mdw252. Epub 2016 Jul 20.
PMID: 27443634DERIVEDVardy J, Dhillon HM, Pond GR, Rourke SB, Xu W, Dodd A, Renton C, Park A, Bekele T, Ringash J, Zhang H, Burkes R, Clarke SJ, Tannock IF. Cognitive function and fatigue after diagnosis of colorectal cancer. Ann Oncol. 2014 Dec;25(12):2404-2412. doi: 10.1093/annonc/mdu448. Epub 2014 Sep 11.
PMID: 25214544DERIVED
Biospecimen
cytokines, genotyping apoE, EUC, LFTs, sex hormones, coagulation factors
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janette Vardy, MD
Princess Margaret Hospital University of Toronto
- PRINCIPAL INVESTIGATOR
Ian Tannock
Princess Margaret Hospital University of Toronto
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 16, 2005
Study Start
November 1, 2003
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
March 22, 2016
Record last verified: 2016-03