Clinical trial NCT02290834: Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer
Official title: Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Impaired Cognition
Chemo-brain
Breast Cancer
Keywords: Chemotherapy related cognitive impairment
Chemo-brain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 200
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Change in cognitive performance scores
timeFrame: Baseline, immediately after completion of chemo, and 6 months after completion of chemotherapy
Secondary outcomes:
measure: Correlation between baseline amyloid accumulation in the brain and change in cognitive performance
timeFrame: Baseline, 6 months after completion of chemotherapy
measure: Correlation between baseline tau accumulation in the brain and change in cognitive performance
timeFrame: Baseline, 6 months after completion of chemotherapy
measure: 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)
timeFrame: Baseline, 6 months after completion of chemotherapy
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Salem
country: United States
facility: Massachusetts General Hospital/North Shore Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Michael Parsons, PhD
role: PRINCIPAL_INVESTIGATOR
References: