Cognitive Function and Fatigue in Colorectal Cancer (CRC) Patients After Chemotherapy - Full Text View

Sponsors and Collaborators:	University Health Network, Toronto National Cancer Institute of Canada Young Investigator Award - American Society of Clinical Oncologists Peterborough K.M. Hunter Graduate Studentship
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00188331

Purpose

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.

Condition	Intervention
Cognition Fatigue Colorectal Neoplasm	Behavioral: Neuropsychological Testing

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Cognitive Function and Fatigue in Cancer Patients After Chemotherapy: A Longitudinal Controlled Study in Patients With Colorectal Cancer

Further study details as provided by University Health Network, Toronto:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

cytokines, genotyping apoE, EUC, LFTs, sex hormones, coagulation factors

Estimated Enrollment:	360
Study Start Date:	November 2003

Groups/Cohorts	Assigned Interventions
1 adjuvant/neoadjuvant chemotherapy	Behavioral: Neuropsychological Testing neuropsychological testing with traditional tests, CANTAB and six elements test as well as questionnaires
2 non-chemotherapy group	Behavioral: Neuropsychological Testing 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	Behavioral: Neuropsychological Testing neuropsychological testing with traditional tests, CANTAB and six elements test as well as questionnaires

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

colorectal cancer patients aged 18-75

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188331

Contacts

Contact: Janette Vardy, MD	61297675000	jvardy@med.usyd.edu.au
Contact: Ian Tannock, MD	1416 946 2245	ian.tannock@uhn.on.ca

Locations

Australia, New South Wales
Sydney Cancer Centre	Recruiting
Sydney, New South Wales, Australia, 2139
Contact: Janette Vardy, MD PhD 61297675000 jvardy@med.usyd.edu.au
Principal Investigator: Janette Vardy
Canada, Ontario
University Health Network	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Ian Tannock, MD 1 416 946 2245 ian.tannock@uhn.on.ca
Contact: Ian Tannock, MD 1416 946 2245 ian.tannock@uhn.on.ca
Principal Investigator: Ian Tannock, MD

Sponsors and Collaborators

University Health Network, Toronto

National Cancer Institute of Canada

Young Investigator Award - American Society of Clinical Oncologists

Peterborough K.M. Hunter Graduate Studentship

Investigators

Principal Investigator:	Janette Vardy, MD	Princess Margaret Hospital University of Toronto
Principal Investigator:	Ian Tannock	Princess Margaret Hospital University of Toronto

More Information

No publications provided

Responsible Party:	( Ian tannock )
Study ID Numbers:	COIT1, NCIC Grant No. #15261
Study First Received:	September 9, 2005
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00188331 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University Health Network, Toronto:

cognitive function
fatigue
colorectal cancer
chemotherapy
cognitive impairment

Study placed in the following topic categories:

Signs and Symptoms
Digestive System Diseases
Digestive System Neoplasms
Fatigue
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Fatigue
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms

Signs and Symptoms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009