Overview

This trial is active, not recruiting.

Conditions breast cancer, long-term survivors
Treatments mini-mental state exam and blood draw
Sponsor Memorial Sloan Kettering Cancer Center
Start date June 2007
End date June 2017
Trial size 200 participants
Trial identifier NCT00496613, 07-090

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
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
mini-mental state exam and blood draw
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
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
mini-mental state exam and blood draw
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
Healthy women matched on age and education
mini-mental state exam and blood draw
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

Primary Outcomes

Measure
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

Eligibility Criteria

Female participants from 50 years up to 70 years old.

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.

Additional Information

Official title Chemotherapy-Induced Cognitive Change and DNA Damage in Breast Cancer Survivors
Principal investigator Tim Ahles, PhD
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: 1. 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. 2. 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.