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Study to Examine Time-Dependent Neurocognitive Changes in Patients With Breast Cancer Receiving Adjuvant Chemotherapy
This study is currently recruiting participants.
Verified by Memorial Sloan-Kettering Cancer Center, January 2009
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
Weill Medical College of Cornell University
The City College of New York
Brigham and Women's Hospital
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00550134
  Purpose

Patients with cancer often complain that their "mind does not seem to be clear." This can be due to stress, depression or anxiety, or physical problems caused by cancer or the treatments used to control symptoms. There are many purposes for this study; one of them is to learn about the effects of chemotherapy on the brain, and another is to identify useful tools to detect these effects. The results of this study may stimulate new research comparing different treatments to the current treatment so the researchers may learn how to treat symptoms more effectively and improve patient quality of life. We would also like to learn more about the effects chemotherapy may have on DNA.


Condition Intervention
Breast Cancer
Cognitive Side Effects of Cancer Treatments
Stage I, II and III A Breast Cancer
Behavioral: Questionnaires, MRI, Comet assay and Cell senescence

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Anxiety Breast Cancer Cancer Depression Memory
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: A Prospective Longitudinal Study to Examine Time-Dependent Neurocognitive Changes in Patients With Breast Cancer Receiving Adjuvant Chemotherapy

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To evaluate changes in cognitive performance pre- to post-chemotherapy in breast cancer patients receiving AC-T. [ Time Frame: plus or minus 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate associations between changes in frontal cortex and hippocampal volumes and activation patterns and changes in neuropsychological test performance. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • To evaluate the relationship between change in level of oxidative DNA damagemarkers of cell senescence (Telomere attrition) and changes in volume and activation patterns in prefrontal cortex and hippocampus. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

blood


Estimated Enrollment: 105
Study Start Date: October 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1, Non Cancer group
A noncancer control group (N=35), frequency matched on age (< 50 and ≥ 50) and education (less than college or some college and above) will also be recruited and evaluated with the same neuropsychological test battery on a schedule that matches the inter-test interval of the patients.
Behavioral: Questionnaires, MRI, Comet assay and Cell senescence
Neuropsychological and psychological testing MRI, Comet assay and Cell senescence
2 Breast Cancer Patients Scheduled for chemotherapy
We will recruit patients with localized breast cancer undergoing adjuvant chemotherapy for the first time and will test the effects of chemotherapy (doxorubicin and cyclophosphamide followed by paclitaxel (ACT)) on patients' cognitive function utilizing a standardized neuropsychological battery.
Behavioral: Questionnaires, MRI, Comet assay and Cell senescence
Neuropsychological and psychological testing MRI, Comet assay and Cell senescence
3 Breast Cancer Patients Not Scheduled for Chemotherapy
We will recruit patients with localized breast cancer not undergoing adjuvant chemotherapy.
Behavioral: Questionnaires, MRI, Comet assay and Cell senescence
Neuropsychological and psychological testing, MRI, Comet assay and Cell senescence

Detailed Description:

This is a prospective, longitudinal study to examine time-dependent neurocognitive changes in patients with breast cancer receiving adjuvant chemotherapy. This study will assess chemotherapy-induced cognitive dysfunction. The researchers will recruit patients with localized breast cancer undergoing adjuvant chemotherapy for the first time and will test the effects of chemotherapy on patients' cognitive function utilizing a standardized neuropsychological battery. Patients scheduled for treatment with doxorubicin and cyclophosphamide followed by paclitaxel (AC-T) will be given a battery of neuropsychological tests prior to beginning chemotherapy and one month following completion of treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Potential subjects for the study will be identified MSKCC's clinic.

Non-cancer control group participants will be recruited through advertisements and flyers and by asking survivors if they have a friend who might want to volunteer for the study.

Criteria

Inclusion Criteria:

  • Patient is 18 years of age but not older than 70yrs of age
  • Stage I, II and III A breast cancer
  • Patient is female
  • Patient is able to understand English, through verbal and written communication
  • Patient is able to provide informed consent
  • Patient has a diagnosis of breast cancer, limited to localized disease
  • Patient is chemotherapy naïve and is receiving AC-T therapy or is scheduled to receive no chemotherapy as part of adjuvant treatment

Exclusion Criteria:

  • Patient has documented evidence of cognitive compromise (Mini-Mental State Exam score > 20 administered prior to enrollment) or a history neurological disorder with cognitive symptoms (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis)
  • Metal implants that preclude fMRI evaluation
  • Pregnant or lactating
  • Participant is currently on medication for migraine, diabetes or uncontrollable hypertension
  • Participant has a reported fear of enclosed spaces (Claustrophobic)
  • Participant has any of the following items that preclude fMRI evaluation
  • Cardiac pacemaker, Joint replacements, Aneurysm clips, Transdermal patched, Aortic clips Prosthesis, Intracranial bypass clips, Harrington rod , Coronary Artery bypass clips, Biostimulator, Renal Transplant Clips, Bone or joint pins, Other vascular clips or filters, Tissue expander ,Implanted neurostimulators, Metal mesh, Artificial heart valve, Stents, Insulin pump, Wire structures, Electrodes, Shrapnel/bullets, Hearing Aids implant, Implanted electrical devices, IUD, Metal in eyes, Shunts, Ocular Implants, Hair extensions, Hair implants, Tattoos above the waist, Any possible metal in body
  • Participant has dentures, body jewelry or wig that they are unable to remove

History of head injury with evidence of brain injury or loss of consciousness for > 60 minutes or cognitive sequelae

  • Untreated or current episode of depression (answering positively to either of the two screening questions from the PHQ-9 (Kroenke, et al., 2001)
  • Self-reported sleep disorders that could influence cognitive functioning including sleep apnea and chronic fatigue syndrome
  • History of Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia disorder (DSM-IV) or substance use disorders (self reported and/or stated in medical record)
  • History of schizophrenia, bipolar disorder or substance use disorders
  • Patient is unwilling to undergo fMRI component if selected
  • Patient has undergone previous chemotherapy treatment

Healthy Control Inclusion Criteria:

  • 18 years of age or older
  • Female
  • Able to understand English, through verbal and written communication
  • Able to provide informed consent
  • Participant is able to undergo MRI scanning (verified with pre MRI Safety Screening form.)

Healthy Control Exclusion Criteria:

  • Documented evidence of severe cognitive compromise or a neurological disorder with cognitive symptoms (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis).
  • Metal implants that preclude fMRI evaluation
  • Pregnant or lactating
  • Participant is currently on medication for migraine, diabetes or uncontrollable hypertension
  • Participant has a reported fear of enclosed spaces (Claustrophobic)
  • Participant has any of the following items that preclude fMRI evaluation Cardiac pacemaker, Joint replacements, Aneurysm clips, Transdermal patched, Aortic clips Prosthesis, Intracranial bypass clips, Harrington rod , Coronary Artery bypass clips, Biostimulator, Renal Transplant Clips, Bone or joint pins, Other vascular clips or filters, Tissue expander ,Implanted neurostimulators, Metal mesh, Artificial heart valve, Stents, Insulin pump, Wire structures, Electrodes, Shrapnel/bullets, Hearing Aids implant, Implanted electrical devices, IUD, Metal in eyes, Shunts, Ocular Implants, Hair extensions, Hair implants, Tattoos above the waist, Any possible metal in body
  • Participant has dentures, body jewelry or wig that they are unable to remove
  • History of head injury with evidence of brain injury or loss of consciousness for > 60 minutes or cognitive sequelae
  • Untreated or current episode of depression (answering positively to either of the two screening questions from the PHQ-9 (Kroenke, et al., 2001)
  • Self-reported sleep disorders that could influence cognitive functioning including sleep apnea and chronic fatigue syndrome
  • History of Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia disorder (DSM-IV) or substance use disorders (self reported and/or stated in medical record)
  • History of schizophrenia, bipolar disorder or substance use disorders
  • Unwilling to undergo fMRI component if selected
  • Exposure to chemotherapy for non-cancer medical disorder
  • Previous diagnosis of other cancer, except non-melanoma skin cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00550134

Contacts
Contact: Tim Ahles, PhD 646-888-0048 ahlest@mskcc.org
Contact: Steven Passik, PhD 646-888-0022 passiks@mskcc.org

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Steven Passik, PhD     646-888-0022     passiks@mskcc.org    
Principal Investigator: Tim Ahles, PhD            
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Weill Medical College of Cornell University
The City College of New York
Brigham and Women's Hospital
Investigators
Principal Investigator: Tim Ahles, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: Memorial Sloan Kettering Cancer Center ( Tim Ahles, PhD )
Study ID Numbers: 07-130
Study First Received: October 25, 2007
Last Updated: January 6, 2009
ClinicalTrials.gov Identifier: NCT00550134  
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Breast Cancer
Quality of life

Study placed in the following topic categories:
Skin Diseases
Quality of Life
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on February 09, 2009