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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Weill Medical College of Cornell University The City College of New York Brigham and Women's Hospital |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00550134 |
Patients with cancer often complain that their "mind does not seem to be clear." This can be due to stress, depression or anxiety, or physical problems caused by cancer or the treatments used to control symptoms. There are many purposes for this study; one of them is to learn about the effects of chemotherapy on the brain, and another is to identify useful tools to detect these effects. The results of this study may stimulate new research comparing different treatments to the current treatment so the researchers may learn how to treat symptoms more effectively and improve patient quality of life. We would also like to learn more about the effects chemotherapy may have on DNA.
Condition | Intervention |
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Breast Cancer Cognitive Side Effects of Cancer Treatments Stage I, II and III A Breast Cancer |
Behavioral: Questionnaires, MRI, Comet assay and Cell senescence |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | A Prospective Longitudinal Study to Examine Time-Dependent Neurocognitive Changes in Patients With Breast Cancer Receiving Adjuvant Chemotherapy |
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Estimated Enrollment: | 105 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1, Non Cancer group
A noncancer control group (N=35), frequency matched on age (< 50 and ≥ 50) and education (less than college or some college and above) will also be recruited and evaluated with the same neuropsychological test battery on a schedule that matches the inter-test interval of the patients.
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Behavioral: Questionnaires, MRI, Comet assay and Cell senescence
Neuropsychological and psychological testing MRI, Comet assay and Cell senescence
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2 Breast Cancer Patients Scheduled for chemotherapy
We will recruit patients with localized breast cancer undergoing adjuvant chemotherapy for the first time and will test the effects of chemotherapy (doxorubicin and cyclophosphamide followed by paclitaxel (ACT)) on patients' cognitive function utilizing a standardized neuropsychological battery.
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Behavioral: Questionnaires, MRI, Comet assay and Cell senescence
Neuropsychological and psychological testing MRI, Comet assay and Cell senescence
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3 Breast Cancer Patients Not Scheduled for Chemotherapy
We will recruit patients with localized breast cancer not undergoing adjuvant chemotherapy.
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Behavioral: Questionnaires, MRI, Comet assay and Cell senescence
Neuropsychological and psychological testing, MRI, Comet assay and Cell senescence
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This is a prospective, longitudinal study to examine time-dependent neurocognitive changes in patients with breast cancer receiving adjuvant chemotherapy. This study will assess chemotherapy-induced cognitive dysfunction. The researchers will recruit patients with localized breast cancer undergoing adjuvant chemotherapy for the first time and will test the effects of chemotherapy on patients' cognitive function utilizing a standardized neuropsychological battery. Patients scheduled for treatment with doxorubicin and cyclophosphamide followed by paclitaxel (AC-T) will be given a battery of neuropsychological tests prior to beginning chemotherapy and one month following completion of treatment.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Potential subjects for the study will be identified MSKCC's clinic.
Non-cancer control group participants will be recruited through advertisements and flyers and by asking survivors if they have a friend who might want to volunteer for the study.
Inclusion Criteria:
Exclusion Criteria:
History of head injury with evidence of brain injury or loss of consciousness for > 60 minutes or cognitive sequelae
Healthy Control Inclusion Criteria:
Healthy Control Exclusion Criteria:
Contact: Tim Ahles, PhD | 646-888-0048 | ahlest@mskcc.org |
Contact: Steven Passik, PhD | 646-888-0022 | passiks@mskcc.org |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Steven Passik, PhD 646-888-0022 passiks@mskcc.org | |
Principal Investigator: Tim Ahles, PhD |
Principal Investigator: | Tim Ahles, PhD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan Kettering Cancer Center ( Tim Ahles, PhD ) |
Study ID Numbers: | 07-130 |
Study First Received: | October 25, 2007 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00550134 |
Health Authority: | United States: Institutional Review Board |
Breast Cancer Quality of life |
Skin Diseases Quality of Life Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |