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Study of the Effects of Chemotherapy on Memory and Other Mental Functions in Women With Breast Cancer

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ClinicalTrials.gov Identifier: NCT00260975
Recruitment Status : Completed
First Posted : December 2, 2005
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Many breast cancer patients treated with chemotherapy complain of problems with concentration and memory. This has been referred to as chemo fog. The current study is investigating this phenomenon by measuring mental function of breast cancer patients prior to and after exposure to chemotherapy, and by comparing mental function in those patients who receive chemotherapy and those who do not.

Condition or disease
Breast Cancer

Detailed Description:
Many breast cancer patients treated with chemotherapy complain of problems with concentration and memory. This has been referred to as chemo fog. The current study will investigate this phenomenon by measuring neuropsychological functioning in early stage breast cancer patients prior to and after exposure to chemotherapy, and by comparing change in cognitive function in patients who receive chemotherapy to similar breast cancer patients receiving hormonal therapy only.

Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 112 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Longitudinal Investigation of the Neuropsychological and Psychosocial Effects of Cancer Therapy
Study Start Date : June 2001
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Chemotherapy patients
Breast cancer patients treated with adjuvant chemotherapy of various types.
Hormonal patients
Breast cancer patients treated with adjuvant hormonal therapy but not chemotherapy.


Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Breast Cancer
Criteria

Inclusion Criteria:

  • stage I or II breast cancer; woman; 50-65 years old; post-menopausal

Exclusion Criteria:

  • history of previous cancer or chemotherapy; significant neurological or psychiatric history
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260975


Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Breast Cancer Foundation
Investigators
Principal Investigator: Barbara Collins OHRI
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00260975     History of Changes
Other Study ID Numbers: 1999232-01H
First Posted: December 2, 2005    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Keywords provided by Ottawa Hospital Research Institute:
breast cancer
chemotherapy
hormonal therapy
cognitive function
chemo fog

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases