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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT02290834
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Cognitive, functional and subjective assessments — OTHER
    Cognitive and functional assessments
  • MRI — DEVICE
    Magnetic Resonance Imaging (MRI) Scan
  • PET Scan — RADIATION
    Positron Emission Tomography (PET) Scan

Study Details

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

Key Dates

Start date
Mar 31, 2015
Status verified
Mar 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: ARM 1
    Breast cancer patients treated with chemotherapy * Cognitive, functional and subjective assessments (Pre and Post Treatment) * Imaging (Pre and Post Treatment) * Magnetic Resonance Imaging (MRI) Scan * Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan
  • Active Comparator: ARM 2
    Non-treated breast cancer patient control * Cognitive, functional and subjective assessments (Post enrollment and 6-14 months later * Imaging (Post Enrollment and at 8-14 months later) * Magnetic Resonance Imaging (MRI) Scan * Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan
  • Active Comparator: ARM 3
    Healthy control subjects * Cognitive, functional and subjective assessments (Post enrollment and 6-14 months later * Imaging (Post Enrollment and at 8-14 months later) * Magnetic Resonance Imaging (MRI) Scan * Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan

Primary Outcome Measure

Change in cognitive performance scores [ Time Frame: Baseline, immediately after completion of chemo, and 6 months after completion of chemotherapy ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Michael Parsons, PhD
[email protected]
617-643-0282
Michael Parsons, PhD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital/North Shore Cancer CenterSalemMassachusetts01970
Therese Mulvey, MD
[email protected]
678-882-6060
Therese Mulvey, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Massachusetts General Hospital· Boston, MAMassachusetts General Hospital/North Shore Cancer Center· Salem, MA

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