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Chemotherapy for Cognitive Impairment in Breast Cancer

N/A

Recruiting

Led By Michael Parsons, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female subjects age ≥ 60 years.

New diagnosis histologically confirmed invasive breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how well chemotherapy affects cognition and the brain in people with breast cancer.

Who is the study for?

This trial is for women aged 60 or older with a new diagnosis of invasive breast cancer and a life expectancy of at least one year. Participants must be planning to undergo chemotherapy, have good functional status (KPS ≥ 80), and be able to consent. There's also a control group who won't receive chemotherapy.

What is being tested?

The study looks at how chemotherapy affects thinking abilities and brain structure in older adults with breast cancer. It involves cognitive tests, MRI scans, and PET scans to assess changes before and after treatment.

What are the potential side effects?

While the trial itself doesn't involve drugs that cause side effects, it studies the impact of chemotherapy which can include memory issues ('chemobrain'), fatigue, nausea, hair loss, increased infection risk among other potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged 60 years or older.

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I have been newly diagnosed with invasive breast cancer.

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My treatment plan does not involve chemotherapy.

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My treatment plan includes chemotherapy.

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I can carry out normal activities with minimal symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: ARM 1Active Control3 Interventions

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

Group II: ARM 2Active Control3 Interventions

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

Group III: ARM 3Active Control3 Interventions

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

0 / 5Eligibility criteria met