Clinical Trials Directory

Trials / Completed

CompletedNCT00496613

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

Chemotherapy-Induced Cognitive Change and DNA Damage in Breast Cancer Survivors

Status
Completed
Phase
Study type
Observational
Enrollment
200 (estimated)
Sponsor
Memorial Sloan Kettering Cancer Center · Academic / Other
Sex
Female
Age
50 Years – 70 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BEHAVIORALMini-Mental State Exam and Blood drawThe 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
BEHAVIORALMini-Mental State Exam and Blood DrawThe 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
BEHAVIORALMini-Mental State Exam and Blood DrawThe 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

Timeline

Start date
2007-06-01
Primary completion
2022-04-18
Completion
2022-04-18
First posted
2007-07-04
Last updated
2022-04-21

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00496613. Inclusion in this directory is not an endorsement.