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Sponsored by: |
University Health Network, Toronto |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00756132 |
Women with breast cancer undergo treatments that decrease the chance of recurrence of cancer, but are associated with several side effects, including declines in memory and attention and other thinking abilities. The causes of these declines are not known. However, we know that (i) people with cancer may have high levels of molecules in the blood (cytokines) that reflect inflammation; (ii) injection of cytokines into animals, and their use to treat some human diseases, can lead to decreased memory and attention; and (iii) in some advanced cancers cytokines predict disease outcome. This longitudinal study evaluates the relation of cytokines to decreased thinking abilities and to disease outcome over time. Results of this study may help develop interventions to prevent or minimize cognitive decline and identify women who are at high risk for recurrence, and such information could be used in treatment decisions and in the development of new treatment options.
Condition |
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Locally Advanced Breast Cancer |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Role of Inflammatory Markers in Predicting Disease Recurrency and Cognitive Performance in Women With Locally Advanced Breast Cancer (LABC) |
Estimated Enrollment: | 120 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | September 2012 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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Bloods Only
Women aged 18-65 years with a newly diagnosed LABC.
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pCOG
Women aged 18-65 years newly diagnosed with LABC who are willing and able to complete cognitive testing.
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hCOG
Healthy women aged 18-65 years who are willing and able to complete cognitive testing.
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SCIENTIFIC ABSTRACT Background: Women with locally advanced breast cancer (LABC), an aggressive form of breast cancer, undergo combined treatment including chemotherapy, surgery, irradiation, and hormonal treatment. These treatments decrease the chance of recurrence of cancer, but are associated with several side effects, including cognitive difficulties. About one third of breast cancer patients treated with chemotherapy report sustained decline in thinking abilities ('chemofog') after treatment. The causes for cognitive declines are not known. However there is recent information that: (i) people with cancer may have high levels of cytokines and other inflammatory molecules in the blood; (ii) injection of cytokines into animals, and their use to treat some human diseases, can lead to problems in memory and other cognitive abilities; (iii) some survivors of breast cancer have very high cytokine levels with no evidence that their cancer is still active and (iv) in some advanced cancers different cytokines and other inflammatory markers have prognostic information for disease outcome. Genetic polymorphisms of neuronal proteins (APOe, BDNF, COMT) are predictive for cognitive decline in non-cancer population). Objective: This longitudinal study will determine whether serum levels of cytokines and other inflammatory markers are related to 1) cognitive dysfunction; and 2) recurrence of disease in women with LABC. Method: In 120 women with LABC relation of cytokines and inflammatory markers to cancer recurrence will be evaluated; blood will be drawn pre-chemotherapy (at baseline), pre-surgery and then 1 and 2 years after diagnosis. In subset of 60 women with LABC cognitive performance will be evaluated at similar times as blood will be drawn. Similarly, a control group of 60 healthy women will be evaluated for cytokines and cognitive performance. We will also evaluate the predictive role of polymorphisms in genes encoding the neuronal proteins APOe, BDNF, and COMT for cognitive impairment. Data Analysis: The impact of cytokine levels and other inflammatory markers on cognitive performance over time will be evaluated using mixed model regression. Multivariate model will be applied to assess the impact of LABC and chemotherapy on cognitive functions. Cox proportional-hazard model will evaluate the relationship of cytokines and other blood markers on Time-To-Progression to identify variables that predict reoccurrence. Hypotheses: Cytokines and inflammatory markers are related to cognitive impairment and in disease outcome in women with LABC. Genetic polymorphisms of neuronal proteins (APOe, BDNF, and COMT) are predictive for increased cognitive decline after diagnoses and treatment of LABC. Implications: Increased knowledge about the causes of cognitive problems in women with breast cancer should allow development of strategies to prevent or minimize these unpleasant symptoms. Cytokines and other biomarkers might be predictive for disease outcome in women with breast cancer and used in tailoring of adjuvant treatment and as potential targets in development of new therapies.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Women ages 18-65 with a newly diagnosed locally advanced breast cancer and healthy women ages 18-65.
Inclusion Criteria:
Exclusion Criteria:
Contact: Anna J Dodd | 4169464501 ext 3176 | anna.dodd@uhn.on.ca |
Contact: Lori Bernstein, PhD | 4169464501 ext 3695 | lori.bernstein@uhn.on.ca |
Canada, Ontario | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Anna Dodd 4169464501 anna.dodd@uhn.on.ca | |
Contact: Lori Bernstein, PhD 416-946-4501 ext 3695 lori.bernstein@uhn.on.ca | |
Principal Investigator: Lori Bernstein, PhD | |
Sub-Investigator: Bostjan Seruga, MD |
Principal Investigator: | Lori Bernstein, PhD | University Health Network, Princess Margaret Hospital |
Principal Investigator: | Bostjan Seruga, MD | PMH UHN |
Responsible Party: | University Health Network, Princess Margaret Hospital ( Dr. Lori Bernstein ) |
Study ID Numbers: | BernLCyto-Cog |
Study First Received: | September 17, 2008 |
Last Updated: | September 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00756132 History of Changes |
Health Authority: | Canada: Health Canada |
Breast Neoplasm Locally Advanced Stage IV |
Stage III Cognitive Function Cytokines Inflammatory |
Skin Diseases Breast Neoplasms Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |