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ARM 1 for Cognitive Impairment

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 baseline, 6 months after completion of chemotherapy

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 ~ baseline, immediately after completion of chemo, and 6 months after completion of chemotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, immediately after completion of chemo, and 6 months after completion of chemotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately after completion of chemo, and 6 months after completion of chemotherapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in cognitive performance scores

Secondary outcome measures

Correlation between baseline amyloid accumulation in the brain and change in cognitive performance

Correlation between baseline tau accumulation in the brain and change in cognitive performance

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)

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

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,198,281 Total Patients Enrolled

Michael Parsons, PhDPrincipal InvestigatorMassachusetts General Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings to participate in this research trial?

"It appears that this clinical trial is still open for recruitment, as the information posted on clinicaltrials.gov has been recently updated (January 19th 2021). The research was initially published March 1st 2015."

Answered by AI

What is the upper limit on participants taking part in this experiment?

"Affirmative. Clinicaltrials.gov attests that this clinical trial, which was initially published on March 1st 2015 is currently recruiting participants. 200 patients need to be enrolled from 2 distinct medical facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Michael W Parsons 2015. "Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02290834.

All > Breast Cancer Boston > Paid Studies Massachusetts