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CompletedNCT00496613Updated Apr 21, 2022

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

An observational study in Breast Cancer and Long-Term Survivors, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 3 sites in United States. Open to female participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-21.

Sponsored by Memorial Sloan Kettering Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
50 Years to 70 Years
Sex
Female
01

Study 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.

Read the 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.
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Conditions studied

  • Breast Cancer
  • Long-Term Survivors

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Keywords

  • Breast cancer
  • survivor
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 200 is close to the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Survivors Healthy women

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

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)

Groups and cohorts

  • 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

  • BehavioralMini-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

  • BehavioralMini-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

  • BehavioralMini-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

06

What researchers measure

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.

    Time frame: 2 years

07

Study locations

3 sites
  • Memorial Sloan Kettering Cancer Center at Commack
    Commack, New York, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10021, United States
  • Memorial Sloan Kettering Cancer Center at Mercy Medical Center
    Rockville Centre, New York 11570, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00496613
Lead sponsor
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
Jul 4, 2007
Start date
Jun 2007
Primary completion
Apr 18, 2022
Completion
Apr 18, 2022
Last update
Apr 21, 2022

Study contacts

Tim Ahles, PhD
principal investigator · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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