Chemotherapy-Induced Changes to Cognition and DNA in Breast Cancer Survivors

NCT ID: NCT00496613

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2022-04-18

Brief 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.

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:

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.

Conditions

Breast Cancer; Long-Term Survivors

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

Mini-Mental State Exam and Blood draw

Intervention Type: BEHAVIORAL

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

Mini-Mental State Exam and Blood Draw

Intervention Type: BEHAVIORAL

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

Mini-Mental State Exam and Blood Draw

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• 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

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.

• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tim Ahles, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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

Countries

United States

Related Links

http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

07-090

Identifier Type: -

Identifier Source: org_study_id