Chemotherapy-Induced Changes to Cognition and DNA in Breast Cancer Survivors
Completed
Conditions studied: Breast Cancer, Long-Term Survivors
In brief
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.
Key facts
- Study ID
- NCT00496613
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 200
- Starts
- 2007-06-01
- Expected to finish
- 2022-04-18
- Last updated by the study team
- 2022-04-21
Who can join
Age: 50 and older, up to 70. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Memorial Sloan Kettering Cancer Center at Commack — Commack, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Memorial Sloan Kettering Cancer Center at Mercy Medical Center — Rockville Centre, New York, United States
Full record on ClinicalTrials.gov
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