- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00188331
Cognitive Function and Fatigue in Colorectal Cancer (CRC) Patients After Chemotherapy
March 21, 2016 updated by: University Health Network, Toronto
Cognitive Function and Fatigue in Cancer Patients After Chemotherapy: A Longitudinal Controlled Study in Patients With Colorectal Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
441
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
colorectal cancer patients aged 18-75
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
adjuvant/neoadjuvant chemotherapy
|
neuropsychological testing with traditional tests, CANTAB and six elements test as well as questionnaires
|
2
non-chemotherapy group
|
neuropsychological testing with traditional tests, CANTAB and six elements test as well as questionnaires
|
3
limited metastatic disease or localised recurrence to receive first line metastatic chemotherapy
|
neuropsychological testing with traditional tests, CANTAB and six elements test as well as questionnaires
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Janette Vardy, MD, Princess Margaret Hospital University of Toronto
- Principal Investigator: Ian Tannock, Princess Margaret Hospital University of Toronto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Dhillon 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.
- Vardy 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.
- Vardy 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2003
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
March 22, 2016
Last Update Submitted That Met QC Criteria
March 21, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COIT1
- NCIC Grant No. #15261
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fatigue
-
Bakulev Scientific Center of Cardiovascular SurgeryFoundation for the Support of Physical Culture and Sports BECOME A CHAMPION; Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPIONNot yet recruitingEfficacy, Self | Fatigue, Mental | Fatigue; Muscle, Heart | Fatigue; CombatRussian Federation
-
Universita di VeronaUniversity of Southern CaliforniaCompletedDiet, Healthy | Fasting | Fatigue, Mental | Fatigue; Muscle, HeartItaly
-
Supplement Formulators, Inc.Completed
-
University of ZurichRecruitingVocal FatigueSwitzerland
-
KU LeuvenCompleted
-
Société des Produits Nestlé (SPN)Maastricht University Medical CenterCompleted
-
University of Applied Sciences for Health Professions...University of Wisconsin, MilwaukeeCompleted
-
Taoyuan General HospitalCompleted
-
Alaa Yousri Mahmoud AtiaUnknownMuscle FatigueEgypt
-
University Hospital, Clermont-FerrandLaboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques...CompletedNeuromuscular FatigueFrance
Clinical Trials on Neuropsychological Testing
-
Fondazione Policlinico Universitario Agostino Gemelli...Recruiting
-
Stanford UniversityWashington University School of Medicine; University of Wisconsin, MadisonCompletedCarotid Artery StenosisUnited States
-
University of South FloridaUnknown
-
University of South FloridaMayo Clinic; Florida Department of Health; Mt. Sinai Medical Center, MiamiUnknown
-
Hadassah Medical OrganizationWithdrawn
-
Ohio State UniversityBrain Test, Inc.Active, not recruitingDementia | Mild Cognitive ImpairmentUnited States
-
University Hospital, RouenUnknownCerebrovascular Disorders | Brain Lesions | Degenerative Diseases | Developmental PathologyFrance
-
Charite University, Berlin, GermanyNot yet recruiting
-
Stanford UniversityNot yet recruiting
-
Rehabilitation Hospital of IndianaNot yet recruitingNeuropsychology | Testing