Chemotherapy-Induced Changes to Cognition and DNA in Breast Cancer Survivors
April 20, 2022 updated by: Memorial Sloan Kettering Cancer Center
Chemotherapy-Induced Cognitive Change and DNA Damage in Breast Cancer Survivors
The purpose of this study is to learn more about how chemotherapy affects an individual's thinking abilities (cognition).
Some research has shown that chemotherapy can cause changes in cognition in breast cancer survivors.
However, it is not clear why this change occurs.
In this study, the investigators will look to see if damage to DNA is related to these changes in cognition.
Specifically, the investigators want to see 1) if women who have been treated with chemotherapy have more DNA damage than healthy women; and 2) if DNA damage is related to cognitive problems in breast cancer survivors and healthy women.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary objective of this proposal is to obtain preliminary data regarding the association between DNA damage and cognitive functioning in breast cancer survivors. Specifically, we predict that:
- Breast cancer survivors treated with chemotherapy and hormonal therapy will have higher levels of DNA damage as measured by the Comet assay as compared to age and education matched survivors treated with hormonal therapy only and healthy controls.
- Survivors who meet criteria for cognitive impairment will have higher levels of DNA damage as compared to cancer survivors who do not meet criteria for cognitive impairment and healthy controls.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Commack, New York, United States
- Memorial Sloan Kettering Cancer Center at Commack
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New York, New York, United States, 10021
- Memorial Sloan Kettering Cancer Center
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Rockville Centre, New York, United States, 11570
- Memorial Sloan Kettering Cancer Center at Mercy Medical Center
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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 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Survivors Healthy women
Description
Inclusion Criteria:
- Breast cancer survivors (Stage I-III) 2-6 years post all cancer treatments, but currently receiving hormone therapy.
- History of treatment with chemotherapy and/or hormonal therapy, or hormone therapy only.
- No evidence of active/recurrent disease.
- Less than 70 years old at time of recruitment.
- Post-menopausal prior to initial treatment.
- In the judgment of the consenting professional, is able to provide informed consent.
- Patient is able to understand English, through verbal and written communication.
Exclusion Criteria:
- Recurrence of breast cancer or diagnosis of another cancer except basal cell carcinoma.
- Exposure to chemotherapy or radiation therapy for any medical condition unrelated to breast cancer.
- Neurobehavioral risk factors including history of neurological disorder, or moderate to severe head trauma (loss of consciousness > 60 min or evidence of structural brain changes on imaging).
- Neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, etc.
- Self-reported sleep disorders that could influence cognitive functioning including sleep apnea and chronic fatigue syndrome.
- Self-reported Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia.
- Disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia.
- Male.
Healthy Control Inclusion Criteria:
- Have had no diagnosis of cancer except basal cell carcinoma.
- Less than 70 years old at time of recruitment.
- Post-menopausal.
- In the judgment of the consenting professional, is able to provide informed consent.
- Patient is able to understand English, through verbal and written communication
Healthy Control Exclusion Criteria:
- Exposure to chemotherapy or radiation therapy for any medical condition.
- Neurobehavioral risk factors including history of neurological disorder, or moderate to severe head trauma (loss of consciousness > 60 min or evidence of structural brain changes on imaging).
- Neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease, multiple sclerosis etc.
- Self-reported sleep disorders that could influence cognitive functioning including sleep apnea and chronic fatigue syndrome.
- Self-reported Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia.
- Male.
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 |
Intervention / Treatment |
|---|---|
|
1
Breast cancer survivors (2-6 years post-treatment) who were post-menopausal at the time of diagnosis and treated with a combination of chemotherapy and hormonal therapy, matched on age and education
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The neuropsychological testing will be conducted by a psychometrician who will be trained and supervised by Dr. Correa.
It should take approximately 2 hours to complete.Two blood samples will be collected in green top tubes for analysis of DNA damage
|
|
2
Breast cancer survivors (2-6 years post-treatment) who were post-menopausal at the time of diagnosis and treated with hormonal therapy only matched on age and education
|
The neuropsychological testing will be conducted by a psychometrician who will be trained and supervised by Dr. Correa.
It should take approximately 2 hours to complete.Two blood samples will be collected in green top tubes for analysis of DNA damage
|
|
3
Healthy women matched on age and education
|
The neuropsychological testing will be conducted by a psychometrician who will be trained and supervised by Dr. Correa.
It should take approximately 2 hours to complete.Two blood samples will be collected in green top tubes for analysis of DNA damage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The primary goal of this preliminary study is to examine the relationship between DNA damage and chemotherapy-induced cognitive changes in breast cancer survivors.
Time Frame: 2 years
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
Helpful Links
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, 2007
Primary Completion (Actual)
April 18, 2022
Study Completion (Actual)
April 18, 2022
Study Registration Dates
First Submitted
July 3, 2007
First Submitted That Met QC Criteria
July 3, 2007
First Posted (Estimate)
July 4, 2007
Study Record Updates
Last Update Posted (Actual)
April 21, 2022
Last Update Submitted That Met QC Criteria
April 20, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-090
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.