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Cognitive Changes Associated With Breast Cancer Treatment | Clinical Trials | Clareo Health

COMPLETED

Cognitive Changes Associated With Breast Cancer Treatment

NCT00550134•Memorial Sloan Kettering Cancer Center

Summary

Patients with cancer often complain that their "mind does not seem to be clear." This can be due to stress, depression, 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 cancer treatments 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.

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 chemotherapy will be given a battery of neuropsychological undergo MRI evaluation prior to beginning chemotherapy and one month following completion of treatment.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

Yes

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.
•Participant is 18 years of age but not older than 70 years of age,
+5 more criteria

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
+19 more criteria

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

October 24, 2007

Primary Completion Date

December 28, 2021

Completion Date

December 28, 2021

Last Updated

December 30, 2021

Enrollment

ACTUAL participants

Conditions

Breast CancerCognitive Side Effects of Cancer TreatmentsStage I, II and III A Breast Cancer

Interventions

Questionnaires, MRI, Comet assay and Cell senescence

BEHAVIORAL

Questionnaires, MRI, Comet assay and Cell senescence

BEHAVIORAL

Questionnaires, MRI, Comet assay and Cell senescence

BEHAVIORAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Cognitive Changes Associated With Breast Cancer Treatment

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer