Breast CancerNCT00496613
Chemotherapy-Induced Changes to Cognition and DNA in Breast Cancer Survivors
An observational study of Breast Cancer and Long-Term Survivors, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Long-Term Survivors
- What is being tested?
- Mini-Mental State Exam and Blood draw
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2007to 18 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Survivors Healthy women
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Memorial Sloan Kettering Cancer Center at Commack
Commack, New York
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Memorial Sloan Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, 11570
About this study
Official title: Chemotherapy-Induced Cognitive Change and DNA Damage in Breast Cancer Survivors
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:
- 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.
- 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
- Breast Cancer, Long-Term Survivors
- Being tested
- Mini-Mental State Exam and Blood draw
- Keywords
- Breast cancer, survivor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-Mental State Exam and Blood drawBehavioural
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
Mini-Mental State Exam and Blood DrawBehavioural
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
Mini-Mental State Exam and Blood DrawBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Mini-Mental State Exam and Blood Draw | |
| 3 | Healthy women matched on age and education Receives: Behavioral: Mini-Mental State Exam and Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary goal of this preliminary study is to examine the relationship between DNA damage and chemotherapy-induced cognitive changes in breast cancer survivors.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
- Study startJun 2007
- Primary completion18 Apr 2022
- Study completion18 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tim Ahles, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496613
- Sponsor's protocol ID
- 07-090
- Status last verified
- Apr 2022
- First submitted
- 3 Jul 2007
- Last updated
- 21 Apr 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy-Induced Cognitive Change and DNA Damage in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT00496613
- Acronym / sponsor ID
- 07-090
- Conditions
- Breast Cancer, Long-Term Survivors
- Keywords
- Breast cancer, survivor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- 18 Apr 2022 (actual)
- Study completion
- 18 Apr 2022 (actual)
- First posted
- 4 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: Mini-Mental State Exam and Blood drawBreast 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 |
| 2 | – | Behavioral: Mini-Mental State Exam and Blood DrawBreast 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 |
| 3 | – | Behavioral: Mini-Mental State Exam and Blood DrawHealthy women matched on age and education |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Survivors Healthy women
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini-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 | Behavioural | 1 |
| Mini-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 | Behavioural | 2 |
| Mini-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 | Behavioural | 3 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Ahles, PhD principal investigator
Memorial Sloan Kettering Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Long-Term Survivors, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.