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1

Cognitive-Sparing Stereotactic Radiosurgery for Brain Metastasis

UCSD Image-Guided Cognitive-Sparing Radiosurgery for Brain Metastases: Avoidance of Eloquent White Matter and Hippocampal Regions

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of cognitive-sparing stereotactic radiosurgery.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). You must have at least 1 brain tumor that has not been treated with radiation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive-sparing stereotactic radiosurgery</li> <li class="seamTextUnorderedListItem">MRI scans, 4 scans within 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive tests</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule.</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Cognitive-sparing stereotactic radiosurgery is a targeted radiation therapy that avoids the white matter and hippocampus (parts of the brain that control memory, language, attention, and <span class="highlight">cognition).</li></span> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04343157' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
1

Cognitive-Sparing Stereotactic Radiosurgery for Brain Metastasis

UCSD Image-Guided Cognitive-Sparing Radiosurgery for Brain Metastases: Avoidance of Eloquent White Matter and Hippocampal Regions
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Nearest Location:
449 miles
Moores Cancer Center
San Diego, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04343157

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Phase II

2

Studying Speech, Movement, and Senses During Brain Surgery for Brain Metastasis

Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors

Purpose: To study how brain tumors affect your speech, movement, and senses and to develop new methods of diagnosing brain tumors.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive testing</li> <li class="seamTextUnorderedListItem">MRI and fMRI scans</li> <li class="seamTextUnorderedListItem">DTI tractograms</li> <li class="seamTextUnorderedListItem">MEG studies</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Awake brain mapping and surgery to remove brain tumor</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A craniotomy is a type of brain surgery. The surgeon will remove part of your skull (cranium) to access your brain to remove the tumors.</li> <li class="seamTextUnorderedListItem">You will be awake during the craniotomy to monitor how the surgery is affecting your speech, movement, and senses. Your scalp will be anesthetized, so you will not feel the operation or any pain.</li> <li class="seamTextUnorderedListItem">You will receive cognitive testing, MRI and fMRI scans, DTI tractograms, and MEG studies before and after surgery.</li> <li class="seamTextUnorderedListItem">Cognitive tests study your <span class="highlight">cognition,</span> which is your ability to think.</li> <li class="seamTextUnorderedListItem">Magnetic resonance imaging (MRI) and functional magnetic resonance imaging (fMRI) scans produce brain images created by magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">A DTI tractogram is a type of MRI scan that produces brain images created by radio waves and magnetic fields.</li> <li class="seamTextUnorderedListItem">MEG studies measure the magnetic fields produced by your brain.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01535430' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://braintumorcenter.ucsf.edu/treatments/surgery/awake-brain-mapping-faq' target='_blank'>UCSF Brain Tumor Center: Awake Craniotomy</a> </li></ul>
2

Studying Speech, Movement, and Senses During Brain Surgery for Brain Metastasis

Assessment of Reorganization and Plasticity of Eloquent Function in Patients With Brain Tumors
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Nearest Location:
1418 miles
University of Nebraska Medical Center
Omaha, NE

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Visits:
May require hospitalization

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ClinicalTrials.gov: NCT01535430

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Phase NA

3

Memantine for <span class="highlight">Cognition</span> with Whole Brain Radiation Therapy for Brain Metastasis

Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique (ONCO-RT) - A Phase II Trial of Upfront Pulsed Reduced Dose Rate Whole-Brain Radiation Therapy for Brain Metastases

Purpose: To study the effects (good and bad) of memantine and whole brain radiation therapy (WBRT) on your <span class="highlight">cognition</span> (ability to think).

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Memantine (Namenda®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Whole brain radiation therapy (WBRT) with pulsed reduced dose rate (PRDR), daily for 10 days</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive testing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Whole brain radiation therapy (WBRT) is radiation therapy that treats the entire brain.</li> <li class="seamTextUnorderedListItem">WBRT with pulsed reduced dose rate (PRDR) uses a slower rate of radiation to improve safety and anti-cancer activity.</li> <li class="seamTextUnorderedListItem">Memantine (Namenda®) is a medication that treats <span class="highlight">cognition</span> (ability to think).</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05045950' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.webmd.com/drugs/2/drug-77932-377/memantine-oral/memantine-oral/details' target='_blank'>WebMD: Memantine</a> </li></ul>
3

Memantine for <span class="highlight">Cognition</span> with Whole Brain Radiation Therapy for Brain Metastasis

Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique (ONCO-RT) - A Phase II Trial of Upfront Pulsed Reduced Dose Rate Whole-Brain Radiation Therapy for Brain Metastases
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Nearest Location:
1832 miles
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, WI

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Visits:
Daily for 10 days

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ClinicalTrials.gov: NCT05045950

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Phase II

4

MIND Diet and Nutrition Counseling to Improve Brain Function for People with Stage II-IV HR+ Breast Cancer

Protecting the Brain From Toxic Side Effects of Chemotherapy: a Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Breast Cancer

Purpose: To study the impact of the Neurodegenerative Delay (MIND) diet on your <span class="highlight">cognition</span> (ability to think).

Who is this for?: Postmenopausal women 45 to 75 years old with stage II, stage III, or stage IV (metastatic) hormone receptor positive (ER+ and/or PR+) breast cancer who are planning to begin treatment within 1 month. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nutrition counseling about the MIND diet, 8 in-person sessions within 3 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">General health (non-diet) counseling, 8 in-person sessions within 3 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cancer treatment can lead to <span class="highlight">cognition</span> (ability to think) problems and low quality of life.</li> <li class="seamTextUnorderedListItem">The Neurodegenerative Delay (MIND) diet is high in anti-inflammatory nutrients (omega-3, carotenoids, B vitamins, etc.) and limits foods that are not healthy for the brain (butter, cheese, red meat, fried foods, sugar, etc.).</li> <li class="seamTextUnorderedListItem">The MIND diet may help improve brain function during cancer treatment.</li> <li class="seamTextUnorderedListItem">Cognition is your ability to think.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05984888' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://health.osu.edu/wellness/exercise-and-nutrition/the-mind-diet' target='_blank'>Ohio State University: The MIND Diet and Brain Health</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/diseases/21032-chemo-brain' target='_blank'>Cleveland Clinic: Chemotherapy and Brain Function Problems</a> </li></ul>
4

MIND Diet and Nutrition Counseling to Improve Brain Function for People with Stage II-IV HR+ Breast Cancer

Protecting the Brain From Toxic Side Effects of Chemotherapy: a Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Breast Cancer
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Nearest Location:
2108 miles
Ohio State University Comprehensive Cancer Center
Columbus, OH

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Visits:
8 visits within 9 months

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ClinicalTrials.gov: NCT05984888

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Phase NA

5

Studying the Effect of Tumor Location on <span class="highlight">Cognition</span> and Muscle Control for Brain Metastasis

Perioperative Evaluation of Cerebellar Tumors: Impact of Cerebellar Functional Topography on <span class="highlight">Cognition</span> and Motor Ataxia

Purpose: To study the effect of the location of brain tumors on <span class="highlight">cognition</span> and muscle control.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) who are planning to receive surgery. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care surgery to remove brain tumor</li> <li class="seamTextUnorderedListItem">MRI scan, 7 times within 2 years</li> <li class="seamTextUnorderedListItem">Cognitive tests, 1 time</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your brain tumor will be removed during a standard of care brain surgery.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">Cognition is your ability to think.</li> <li class="seamTextUnorderedListItem">Cognitive tests measure your ability to think.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04463979' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
5

Studying the Effect of Tumor Location on <span class="highlight">Cognition</span> and Muscle Control for Brain Metastasis

Perioperative Evaluation of Cerebellar Tumors: Impact of Cerebellar Functional Topography on <span class="highlight">Cognition</span> and Motor Ataxia
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Nearest Location:
2385 miles
Duke University Medical Center
Durham, NC

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Visits:
7 visits within 2 years

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ClinicalTrials.gov: NCT04463979

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Phase NA

6

Preserving Cognitive Function With Whole Brain Radiation Therapy for Brain Metastases

Preservation of <span class="highlight">Cognition</span> and Neuropsychiatric Functioning With Corpus Callosum Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases: A Pilot Study

Purpose: To evaluate how well genu-sparing whole brain radiation preserves cognitive function in patients with brain metastases.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) that has not been treated with whole brain radiation therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genu-sparing whole brain radiation therapy, once a day, 5 days a week</li> <li class="seamTextUnorderedListItem">Cognitive testing at baseline and at 4 , 6 and 12 months following completion of brain radiation</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genu-sparing whole brain radiation limits the radiation dose to a specific area in the brain (the genu of the corpus callosum).</li> <li class="seamTextUnorderedListItem">The genu (front part) of the corpus callosum is associated with cognitive and neuropsychiatric functioning.</li> <li class="seamTextUnorderedListItem">Researchers believe that reducing damage to this area may prevent the decline of cognitive and neuropsychiatric functioning.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03223922' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
6

Preserving Cognitive Function With Whole Brain Radiation Therapy for Brain Metastases

Preservation of <span class="highlight">Cognition</span> and Neuropsychiatric Functioning With Corpus Callosum Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases: A Pilot Study
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Nearest Location:
2433 miles
Sibley Memorial Hospital
Washington, DC

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Visits:
Please contact the research site

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ClinicalTrials.gov: NCT03223922

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Phase NA

7

Brain Surgery for Brain Metastasis and Tumor Related Epilepsy

Tumor Related Epilepsy

Purpose: To study if brain surgery reduces the number of seizures and to see how surgery affects seizures.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). You must have no more than one brain tumor and have experienced at least one seizure associated with the tumor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery to remove brain tumor</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires hospitalization for at least one week</li> <li class="seamTextUnorderedListItem">Questionnaires, cognitive assessments, and seizure diary</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some people with brain tumors have seizures related to the tumor. This is called tumor-related epilepsy. </li> <li class="seamTextUnorderedListItem">Researchers think surgery may improve outcomes for people with tumor-related epilepsy by stopping seizures or reducing the number of seizures.</li> <li class="seamTextUnorderedListItem">Cognitive assessments study your <span class="highlight">cognition,</span> which is your ability to think.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02639325' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/brain-metastasis/' target='_blank'>MBCBrainMets.org: About Brain Metastasis</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/treatments-brain-metastasis/#toggle-id-7' target='_blank'>MBCBrainMets.org: Brain Metastasis Treatments</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/brain-mets/' target='_blank'>Metastastic Trial Talk: Treating Breast Cancer Brain Mets</a> </li></ul>
7

Brain Surgery for Brain Metastasis and Tumor Related Epilepsy

Tumor Related Epilepsy
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Nearest Location:
2433 miles
National Institutes of Health Clinical Center
Bethesda, MD

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Visits:
Requires hospitalization

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ClinicalTrials.gov: NCT02639325

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Phase NA

8

2 Types of Whole Brain Radiation Therapy for Brain Metastasis

Randomized Phase II Trial of Normal Tissue Sparing Whole Brain Radiation Therapy (NTS-WBRT) Versus Hippocampal Avoidance Whole Brain Radiation Therapy (HA-WBRT) in Patients With Brain Metastases

Purpose: To compare the safety, effects (good and bad), and anti-cancer activity of 2 types of whole brain radiation therapy (WBRT).

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) that have not received treatment with memantine (Namenda®). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Normal tissue sparing whole brain radiation therapy (NTS-WBRT), 5 sessions per week for 2-3 weeks</li> <li class="seamTextUnorderedListItem">Memantine (Namenda®), by mouth, daily for 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hippocampal avoidance whole brain radiation therapy (HA-WBRT), 5 sessions per week for 2-3 weeks</li> <li class="seamTextUnorderedListItem">Memantine (Namenda®), by mouth, daily for 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li> <li class="seamTextUnorderedListItem">Cognitive testing</li> <li class="seamTextUnorderedListItem">Hearing assessments</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Whole brain radiation therapy (WBRT) is radiation therapy that treats the entire brain.</li> <li class="seamTextUnorderedListItem">Normal tissue sparing whole brain radiation therapy (NTS-WBRT) is a targeted radiation therapy that reduces radiation to tissue that does not need radiation therapy.</li> <li class="seamTextUnorderedListItem">Hippocampal avoidance whole brain radiation therapy (HA-WBRT) is a targeted radiation therapy that avoids the hippocampus (part of the brain that controls learning and memory) during radiation therapy.</li> <li class="seamTextUnorderedListItem">Memantine (Namenda®) is a standard of care medication that treats <span class="highlight">cognition</span> (ability to think).</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05013892' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
8

2 Types of Whole Brain Radiation Therapy for Brain Metastasis

Randomized Phase II Trial of Normal Tissue Sparing Whole Brain Radiation Therapy (NTS-WBRT) Versus Hippocampal Avoidance Whole Brain Radiation Therapy (HA-WBRT) in Patients With Brain Metastases
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Nearest Location:
2694 miles
Massachusetts General Hospital Cancer Center
Boston, MA

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Visits:
5 visits per week for 2-3 weeks

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ClinicalTrials.gov: NCT05013892

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Phase II

9

Fasting at Night to Improve <span class="highlight">Cognition</span> After Chemotherapy for People with Stage I-IV Breast Cancer

The RolE of Prolonged Nightly faSTing to Improve Sleep and <span class="highlight">cOgnition</span> in bREast Cancer Survivors (RESTORE)

Purpose: To study how fasting at night affects health, quality of life, and cognitive ability.

Who is this for?: Women with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who completed chemotherapy at least 3 months ago and who are having cognitive (thinking) problems. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fast at night, 6 nights every week for 2 months</li> <li class="seamTextUnorderedListItem">Health education videos, weekly for 2 months</li> <li class="seamTextUnorderedListItem">Cognitive tests, 2 times in 2 months</li> <li class="seamTextUnorderedListItem">Surveys, 2 times in 2 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Health education videos, weekly for 2 months</li> <li class="seamTextUnorderedListItem">Cognitive tests, 2 times in 2 months</li> <li class="seamTextUnorderedListItem">Surveys, 2 times in 2 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">When you are fasting, you are still allowed to drink water, coffee, and tea.</li> <li class="seamTextUnorderedListItem">Cognitive problems are problems with thinking <span class="highlight">(cognition).</li></span> <li class="seamTextUnorderedListItem">This trial's enrollment will be racially diverse (at least 50% of participants will be Black, Hispanic, and/or Native American).</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06938555' target='_blank'>ClinicalTrials.gov</a> </li></ul>
9

Fasting at Night to Improve <span class="highlight">Cognition</span> After Chemotherapy for People with Stage I-IV Breast Cancer

The RolE of Prolonged Nightly faSTing to Improve Sleep and <span class="highlight">cOgnition</span> in bREast Cancer Survivors (RESTORE)
No Travel Required
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Visits:
No visits required

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ClinicalTrials.gov: NCT06938555

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Phase NA

10

Care and Monitoring at Home for People with Brain Metastasis

Neuro-Oncology Anywhere: Deploying Mayo Clinic's Remote Cognitive Assessment Battery and Wearable Device Monitoring Platform While Assessing the Impact of Metformin on <span class="highlight">Cognition</span> and Quality of Life in Patients With History of Cranial Radiation

Purpose: To study if giving metformin and monitoring can be done at home for people receiving brain radiation or who have previously had brain radiation.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). You must be planning to receive brain radiation or completed brain radiation within the last 3 years. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Metformin, by mouth, daily, 1 year</li> <li class="seamTextUnorderedListItem">FitBit wearable device</li> <li class="seamTextUnorderedListItem">Cognitive tests</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Usual Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care treatment, 1 year</li> <li class="seamTextUnorderedListItem">FitBit wearable device</li> <li class="seamTextUnorderedListItem">Cognitive tests</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain radiation can result in significant negative effects on <span class="highlight">cognition</span> (the ability to clearly think, learn, and remember).</li> <li class="seamTextUnorderedListItem">Cognitive tests study your <span class="highlight">cognition,</span> which is your ability to think.</li> <li class="seamTextUnorderedListItem">Metformin is a drug approved to treat type 2 diabetes (a condition in which the body cannot control the level of sugar in the blood).</li> <li class="seamTextUnorderedListItem">Metformin may also be used to treat cancer and improve your <span class="highlight">cognition</span> (ability to think) and quality of life.</li> <li class="seamTextUnorderedListItem">In this study, a FitBit wearable device will be used to monitor and detect seizures.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06377696' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayo.edu/research/clinical-trials/cls-20567690' target='_blank'>Mayo Clinic: Trial Information Page</a> </li></ul>
10

Care and Monitoring at Home for People with Brain Metastasis

Neuro-Oncology Anywhere: Deploying Mayo Clinic's Remote Cognitive Assessment Battery and Wearable Device Monitoring Platform While Assessing the Impact of Metformin on <span class="highlight">Cognition</span> and Quality of Life in Patients With History of Cranial Radiation
No Travel Required
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Visits:
No visits required

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ClinicalTrials.gov: NCT06377696

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Phase II

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