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

Sponsor:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00496613

Purpose

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.

Condition	Intervention
Breast Cancer Long-Term Survivors	Behavioral: Mini-Mental State Exam and Blood draw Behavioral: Mini-Mental State Exam and Blood Draw

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	Chemotherapy-Induced Cognitive Change and DNA Damage in Breast Cancer Survivors

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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: conclusion of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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	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
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	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
3 Healthy women matched on age and education	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

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.

Eligibility

Ages Eligible for Study:	50 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Survivors Healthy women

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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496613

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, United States
Memorial Sloan-Kettering Cancer Center 1275 York Avenue
New York, New York, United States, 10021
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, United States, 11570

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Tim Ahles, PhD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Tim Ahles, PhD, Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00496613 History of Changes
Other Study ID Numbers:	07-090
Study First Received:	July 3, 2007
Last Updated:	June 15, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Breast cancer
survivor

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on February 09, 2012