Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02290834
• Other study ID #: 14-217
• Status: Recruiting
• Phase: N/A
• Start date: March 2015
• Est. completion date: January 2027

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Edwin Nunez
• Phone: 617-643-4395
• Email: ENUNEZ2[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study evaluates the effect of chemotherapy on cognition (thinking) and the brain in people with breast cancer.

Description:

• This study is being done to study effects of chemotherapy (cancer treatment) on the brain and cognition (thinking). "Chemo-brain" is a term sometimes used to refer to effects of chemotherapy on the brain and cognition (thinking).

• This study is being done to test for "chemo-brain" in older adults with breast cancer treated with chemotherapy, and to identify people who are most likely to be affected. The investigators will look at thinking abilities and brain images before and after chemotherapy to see if it can help identify people at risk for cognitive side effects of the treatment, and to better understand effects of treatment on brain structure and function.

• The investigators are looking for participants who have either been recently recently diagnosed breast cancer participant or a healthy volunteer.

• What is involved in the study:

• Memory and Thinking Tests

• Imaging: Either MRI/or MRI and PET Scans

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2027
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Breast cancer patients treated with chemotherapy- Group 1 (experimental group)

• Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +/- imaging components of study

• New diagnosis histologically confirmed invasive breast cancer

• Treatment plan to include chemotherapy

• Female subjects age = 60 years.

• Life expectancy = 1 year

• Karnofsky Performance Score (KPS) = 80

• Ability to understand and the willingness to sign a written informed consent document.

• Non-treated breast cancer patient controls- Group 2 (control group)

• Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +/- imaging components of study:

• New diagnosis histologically confirmed invasive breast cancer

• Treatment plan does not include chemotherapy

• Age = 60 years.

• Life expectancy = 1 year

• Karnofsky Performance Score (KPS) = 80

• Ability to understand and the willingness to sign a written informed consent document.

• Healthy control subjects- Group 3 (control group)

• Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +/- imaging components of study:

• Age = 60 years.

• Life expectancy = 1 year

• Karnofsky Performance Score (KPS) = 80

• Ability to understand and the willingness to sign a written informed consent document.

• Participants with well-controlled vascular risk factors, such as treated hypertension, treated hyperlipidemia or well-controlled Type II diabetes (glucose levels <250) may be included.

• Serum Pregnancy Testing: STAT quantitative serum hCG pregnancy testing for all women of childbearing potential. Imaging will not start until and unless the test result returns negative.

Exclusion Criteria:

• Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study:

• Participants with clinical or radiographic evidence of metastatic CNS disease

• Subjects with MMSE scores below 24

• Active or history of major psychiatric disorders such as schizophrenia, schizoaffective disorder, major affective disorder in mid-life, or treatment with ECT (Mild depression that is well treated with stable dose of SSRI antidepressants may be allowed).

• Substance abuse within the past 2 years

• Huntington's disease, hydrocephalus or seizure disorder

• In addition to exclusion criteria above, participants who exhibit any of the following conditions at screening will not be eligible for admission into imaging portion of the study:

• Participants with contraindications to MRI (i.e., implanted metal including pacemakers, cerebral spinal fluid shunts, aneurysm clips, artificial heart valves, ear implants or metal/foreign objects in the eyes and those with a history of claustrophobia), injuries to the eyes with metal without X-ray documentation that metal was removed

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemo-brain
• Cognitive Dysfunction
• Impaired Cognition

Intervention

Other:
• Cognitive, functional and subjective assessments
Cognitive and functional assessments

Device:
• MRI
Magnetic Resonance Imaging (MRI) Scan

Radiation:
• PET Scan
Positron Emission Tomography (PET) Scan

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital/North Shore Cancer Center	Salem	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognitive performance scores		Baseline, immediately after completion of chemo, and 6 months after completion of chemotherapy
Secondary	Correlation between baseline amyloid accumulation in the brain and change in cognitive performance		Baseline, 6 months after completion of chemotherapy
Secondary	Correlation between baseline tau accumulation in the brain and change in cognitive performance		Baseline, 6 months after completion of chemotherapy
Secondary	Correlation between change in tau accumulation in the brain (from baseline to 6 months after completion of chemotherapy) and change in cognitive performance (from baseline to 6 months after completion of chemotherapy)		Baseline, 6 months after completion of chemotherapy