Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00550134 : Cognitive Changes Associated With Breast Cancer Treatment
PhaseN/A
AgesMin: 18 Years Max: 70 Years
Eligibility
Inclusion Criteria:

- Patient is 18 years of age but not older than 70years of age

- Patient is female

- Patient is able to understand English, through verbal and written communication

- In the judgment of the investigator and/or the consenting professional patient is
able to provide informed consent

- Patient has a diagnosis of breast cancer (stage 0, I, II or IIIA-C), limited to
localized disease,

- Patient is chemotherapy naïve and is receiving chemotherapy or is scheduled to
receive no chemotherapy as part of adjuvant treatment

- Patient does not report history of prior breast or other cancer with the exception of
non-melanoma skin cancer and/or participants who completed treatment for a previous
cancer at least 5 years ago and have not undergone any chemotherapy.

- Patient is able to undergo MRI scanning (verified with pre MRI Safety Screening
form),

- Patient can comfortably fit inside the MRI machine, verified by back to chest
measurement no more than 10 inches or bust circumference of no more than 48 inches.

Exclusion Criteria:

- Patient has documented evidence of cognitive compromise (Blessed- Orientation Memory
Cognition Test score > 11

- Patient has a history of neurological disorder with cognitive symptoms (e.g.,
Alzheimer's disease, Parkinson's disease, multiple sclerosis)

- Patient is Pregnant as confirmed by urine pregnancy test. Participants who are post
menopausal or have had a hysterectomy do not need a pregnancy test

- Patient is currently on daily medication for migraine or, insulin-dependent diabetes
requiring administration by injection,

- Patient has uncontrollable hypertension as per self report or as documented in the
medical record

- Patient has a reported fear of enclosed spaces (Claustrophobia)

- Patient 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

- Patient 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 and narcolepsy

- 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:

- Participant is 18 years of age but not older than 70 years of age,

- Participant is female

- Participant is able to understand English, through verbal and written communication

- In the judgment of the investigator and/or the consenting professional participant is
able to provide informed consent

- Patient is able to undergo MRI scanning (verified with pre MRI Safety Screening form)

- Patient can comfortably fit inside the MRI machine, verified by back to chest
measurement no more than 10 inches or bust circumference of no more than 48 inches.

Healthy Control Exclusion Criteria:

-Participant has Documented evidence of severe cognitive compromise (Blessed- Orientation
Memory Cognition Test score > 11

- Participant has a history of neurological disorder with cognitive symptoms (e.g.,
Alzheimer's disease, Parkinson's disease, multiple sclerosis).

- Participant is pregnant as indicated by urine pregnancy test,

- As per self report participant is currently on daily medication for migraine, or ,
insulin dependent diabetes requiring administration by injection,

- As per self report participant has uncontrollable hypertension,

- As per self report, participant has a reported fear of enclosed spaces
(Claustrophobia)

- As per self report, 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

- As per self report, participant has dentures, body jewelry or wig that they are
unable to remove

- As per self report, participant has a history of head injury with evidence of brain
injury or loss of consciousness for > 60 minutes or cognitive sequelae

- As per self report, participant has untreated or current episode of depression
(answering positively to either of the two screening questions from the PHQ-9
(Kroenke, et al., 2001)

- As per self report, participant has sleep disorders that could influence cognitive
functioning including sleep apnea and narcolepsy,

- As per self report, participant has history of Axis I psychiatric disorder (DSM-IV),
major affective disorder (untreated), bipolar disorder, schizophrenia disorder
(DSM-IV) or substance use disorders

- As per self report, participant has undergone previous chemotherapy treatment.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00550134      |      Link to official Clinicaltrials.gov listing
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