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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00260975

First Posted: December 2, 2005

Last Update Posted: September 22, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Canadian Breast Cancer Foundation

Information provided by (Responsible Party):

Ottawa Hospital Research Institute

Purpose

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
Breast Cancer


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	A Prospective, Longitudinal Investigation of the Neuropsychological and Psychosocial Effects of Cancer Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer

U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:


Enrollment:	112
Study Start Date:	June 2001
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

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.

Eligibility

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

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

Publications:

Stewart A, Collins B, Mackenzie J, Tomiak E, Verma S, Bielajew C. The cognitive effects of adjuvant chemotherapy in early stage breast cancer: a prospective study. Psychooncology. 2008 Feb;17(2):122-30.

Collins B, Mackenzie J, Stewart A, Bielajew C, Verma S. Cognitive effects of chemotherapy in post-menopausal breast cancer patients 1 year after treatment. Psychooncology. 2009 Feb;18(2):134-43. doi: 10.1002/pon.1379.

Collins B, Mackenzie J, Stewart A, Bielajew C, Verma S. Cognitive effects of hormonal therapy in early stage breast cancer patients: a prospective study. Psychooncology. 2009 Aug;18(8):811-21. doi: 10.1002/pon.1453.


Responsible Party:	Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:	NCT00260975 History of Changes
Other Study ID Numbers:	1999232-01H
First Submitted:	November 30, 2005
First Posted:	December 2, 2005
Last Update Posted:	September 22, 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

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