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

NCT00496613 | Completed

• 1 other identifier: 07-090
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer; Long-Term Survivors

Keywords

Breast cancer; survivor

Outcome Measures

Primary Outcomes (1)

• The primary goal of this preliminary study is to examine the relationship between DNA damage and chemotherapy-induced cognitive changes in breast cancer survivors.

  2 years

Study Arms (3)

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

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

3

Healthy women matched on age and education

Behavioral: Mini-Mental State Exam and Blood Draw

Interventions

Mini-Mental State Exam and Blood Draw 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

1

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Survivors Healthy women

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.
• 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
• 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).

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (3)

Memorial Sloan Kettering Cancer Center at Commack

Commack, New York, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Memorial Sloan Kettering Cancer Center at Mercy Medical Center

Rockville Centre, New York, 11570, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Tim Ahles, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: June 1, 2007
• Primary Completion: April 18, 2022
• Study Completion: April 18, 2022
• Last Updated: April 21, 2022

Record last verified: 2022-04

Locations

US (3)