Clinical trial · Observational
Chemotherapy-Induced Changes to Cognition and DNA in Breast Cancer Survivors
Chemotherapy-Induced Cognitive Change and DNA Damage in Breast Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Long-Term Survivors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mini-Mental State Exam and Blood draw | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- 1
- description
- 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
- interventionNames
- Behavioral: Mini-Mental State Exam and Blood draw
- label
- 2
- description
- 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
- interventionNames
- Behavioral: Mini-Mental State Exam and Blood Draw
- label
- 3
- description
- Healthy women matched on age and education
- interventionNames
- Behavioral: Mini-Mental State Exam and Blood Draw
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available