NCT00260975

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2001

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

6.7 years

First QC Date

November 30, 2005

Last Update Submit

September 20, 2017

Conditions

Breast Cancer

Keywords

breast cancerchemotherapyhormonal therapycognitive functionchemo fog

Study Arms (2)

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.

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Breast Cancer

You may qualify if:

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

You may not qualify if:

  • history of previous cancer or chemotherapy; significant neurological or psychiatric history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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. doi: 10.1002/pon.1210.

    PMID: 17518411RESULT

  • 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.

    PMID: 18551510RESULT

  • 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.

    PMID: 19085975RESULT

MeSH Terms

Conditions

Breast NeoplasmsChemotherapy-Related Cognitive Impairment

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Barbara Collins

    OHRI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2005

First Posted

December 2, 2005

Study Start

June 1, 2001

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

September 25, 2017

Record last verified: 2017-09