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

September 20, 2017 updated by: Ottawa Hospital Research Institute

A Prospective, Longitudinal Investigation of the Neuropsychological and Psychosocial Effects of Cancer Therapy

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Breast Cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Collaborators

Canadian Breast Cancer Foundation

Investigators

  • Principal Investigator: Barbara Collins, OHRI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

November 30, 2005

First Submitted That Met QC Criteria

November 30, 2005

First Posted (Estimate)

December 2, 2005

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 20, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1999232-01H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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