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


N/A
50 Years
70 Years
Open (Enrolling)
Female
Breast Cancer, Long-Term Survivors

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

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

Outcome Time Frame:

conclusion of study

Safety Issue:

No

Principal Investigator

Tim Ahles, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

07-090

NCT ID:

NCT00496613

Start Date:

June 2007

Completion Date:

June 2013

Related Keywords:

  • Breast Cancer
  • Long-Term Survivors
  • Breast cancer
  • survivor
  • Breast Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer Center at CommackCommack, New York  11725
Memorial Sloan-Kettering Cancer Center at Mercy Medical CenterRockville Centre, New York  11570
Memorial Sloan-Kettering Cancer Center 1275 York AvenueNew York, New York  10021