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Cognitive Function and Fatigue in Colorectal Cancer (CRC) Patients After Chemotherapy

This study has been completed.
Sponsor:
Collaborators:
Canadian Cancer Trials Group
Young Investigator Award - American Society of Clinical Oncologists
Peterborough K.M. Hunter Graduate Studentship
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188331
First received: September 9, 2005
Last updated: March 21, 2016
Last verified: March 2016
  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

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

Resource links provided by NLM:


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

Biospecimen Retention:   Samples With DNA
cytokines, genotyping apoE, EUC, LFTs, sex hormones, coagulation factors

Enrollment: 441
Study Start Date: November 2003
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Australia, New South Wales
Sydney Cancer Centre
Sydney, New South Wales, Australia, 2139
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Canadian Cancer Trials Group
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00188331     History of Changes
Other Study ID Numbers: COIT1  NCIC Grant No. #15261 
Study First Received: September 9, 2005
Last Updated: March 21, 2016
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
cognitive function
fatigue
colorectal cancer
chemotherapy
cognitive impairment

Additional relevant MeSH terms:
Colorectal Neoplasms
Fatigue
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 28, 2016