Breast CancerNCT00260975
Study of the Effects of Chemotherapy on Memory and Other Mental Functions in Women With Breast Cancer
An observational study of Breast Cancer, run by Ottawa Hospital Research Institute.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Jun 2001to Feb 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breast Cancer
Who may be able to join
- stage I or II breast cancer; woman; 50-65 years old; post-menopausal
Who cannot join
- history of previous cancer or chemotherapy; significant neurological or psychiatric history
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- breast cancer, chemotherapy, hormonal therapy, cognitive function, chemo fog
- Medical subject headings
- Breast Neoplasms, Chemotherapy-Related Cognitive Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startJun 2001
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Barbara Collins, Principal investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260975
- Sponsor's protocol ID
- 1999232-01H
- Status last verified
- Sep 2017
- First submitted
- 30 Nov 2005
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1002/pon.1210.
PubMed 17518411Collins 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.
PubMed 18551510Collins 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.
PubMed 19085975
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Longitudinal Investigation of the Neuropsychological and Psychosocial Effects of Cancer Therapy
- ClinicalTrials.gov ID
- NCT00260975
- Acronym / sponsor ID
- 1999232-01H
- Conditions
- Breast Cancer
- Keywords
- breast cancer, chemotherapy, hormonal therapy, cognitive function, chemo fog
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation
- Study start
- Jun 2001
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 2 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breast Cancer
Key inclusion criteria (1 listed)
- stage I or II breast cancer; woman; 50-65 years old; post-menopausal
Key exclusion criteria (1 listed)
- history of previous cancer or chemotherapy; significant neurological or psychiatric history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Results publication: PubMed 17518411Stewart 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.
- Results publication: PubMed 18551510Collins 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.
- Results publication: PubMed 19085975Collins 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Collins principal investigator
OHRI
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Ottawa Hospital Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00260975, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.