Cognitive Changes Associated With Breast Cancer Treatment

NCT00550134 | Completed

• 1 other identifier: 07-130
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Cognitive Side Effects of Cancer Treatments; Stage I, II and III A Breast Cancer

Keywords

Breast Cancer; Quality of life

Outcome Measures

Primary Outcomes (1)

• To evaluate changes in cognitive performance pre- to post-chemotherapy in breast cancer patients.

  approximately 4 to 6 months from baseline, depending on chemotherapy regimen

Secondary Outcomes (2)

• To evaluate associations between changes in frontal cortex and hippocampal volumes and activation patterns and changes in neuropsychological test performance.

  4 to 6 months

• To evaluate the relationship between change in level of oxidative DNA damage markers of cell senescence (Telomere attrition) and changes in volume and activation patterns in prefrontal cortex and hippocampus.

  4 to 6 months

Study Arms (3)

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

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 will be given a battery of neuropsychological tests and an MRI evaluation prior to beginning chemotherapy and approximately one month (plus/minus 4 weeks) following completion of treatment.

Behavioral: Questionnaires, 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

Interventions

Questionnaires, MRI, Comet assay and Cell senescence BEHAVIORAL

Neuropsychological and psychological testing MRI, Comet assay and Cell senescence

Also known as: Wide Range Achievement Test - Reading subtest (WRAT 4, 43), Phonemic Verbal Fluency (44), California Verbal Learning Test II (45), Logical Memory I and II (WMS III, 46), Brown Location Test (47), Paced Auditory Serial Addition Test (PASAT, 48), Trail Making Tests (49), The Trail Making Test (Part B), Grooved Pegboard (50), Digit Symbol (WAIS-III, 62), Continuous Performance Test (CPT, 51), Center for Epidemiological Study - Depression (CES-D, 52), Spielberger State Anxiety Inventory (STAI, 53), Fatigue Symptom Inventory (FSI, 54), Functional Assessment of Cancer Therapy-Cognition (FACT-Cog, 55)

1, Non Cancer group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential subjects for the study will be identified MSKCC's clinic. Healthy control group participants will be recruited through advertisements and flyers which will be available/advertised in the community. Health control participants will also be recruited by asking survivors if they have a friend who might want to volunteer for the study.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Weill Medical College of Cornell University: collaborator
• The City College of New York: collaborator
• Brigham and Women's Hospital: collaborator
• Biomedical Engineering Newark College of Engineering New Jersey Institute of Technology: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires; Magnetic Resonance Spectroscopy; Comet Assay; Cellular Senescence; Memory and Learning Tests; Neuropsychological Tests; 2-cyclohexylidenhydrazo-4-phenyl-thiazole; Multicenter Studies as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Spectrum Analysis; Chemistry Techniques, Analytical; Electrophoresis, Agar Gel; Electrophoresis; Electrochemical Techniques; Mutagenicity Tests; Genetic Techniques; Toxicity Tests; Cell Physiological Phenomena; Aging; Growth and Development; Physiological Phenomena; Psychological Tests; Behavioral Disciplines and Activities; Epidemiologic Study Characteristics

Study Officials

• Tim Ahles, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2007
• First Posted: October 29, 2007
• Study Start: October 24, 2007
• Primary Completion: December 28, 2021
• Study Completion: December 28, 2021
• Last Updated: December 30, 2021

Record last verified: 2021-12

Locations

US (1)