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1

Headband and Meditation for Improving Anxiety and Insomnia for People with Stage I-IV Breast Cancer

Pilot Study of a Wearable EEG Headband as a Meditation Device for Breast Cancer Survivors

Purpose: To study the ability of the MUSE S headband and MUSE phone app to reduce anxiety and insomnia.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who were diagnosed within the last 10 years. You must be experiencing anxiety and insomnia (sleep problems). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MUSE S headband, nightly for 2 months</li> <li class="seamTextUnorderedListItem">Meditation with MUSE phone app, for at least 5 minutes daily, for 2 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anxiety and insomnia (sleep problems) are among the most common side effects of breast cancer.</li> <li class="seamTextUnorderedListItem">Meditation is an effective tool to decrease stress and anxiety.</li> <li class="seamTextUnorderedListItem">The MUSE S headband sends EEG signals to your brain to improve <span class="highlight">fatigue,</span> quality of life, and stress.</li> <li class="seamTextUnorderedListItem">You will be asked to wear the MUSE S headband to bed every night and meditate using the MUSE phone app for at least 5 minutes every day.</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/NCT06274034' target='_blank'>ClinicalTrials.gov</a> </li></ul>
1

Headband and Meditation for Improving Anxiety and Insomnia for People with Stage I-IV Breast Cancer

Pilot Study of a Wearable EEG Headband as a Meditation Device for Breast Cancer Survivors
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Nearest Location:
1615 miles
Mayo Clinic in Rochester
Rochester, MN

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Visits:
Number of visits unavailable, over 2 months

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ClinicalTrials.gov: NCT06274034

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Phase NA

2

Vagus Nerve Stimulator for Insomnia in People with Stage I-IV Breast Cancer

Investigating the Feasibility of Using taVNS to Treat Insomnia in Individuals With Stage I-IV Breast Cancer

Purpose: To study the ability of vagus nerve stimulation to improve sleep, anxiety, depression, and cancer related <span class="highlight">fatigue.</span>

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who have difficulty falling asleep, staying asleep, or waking up too early. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vagus nerve stimulator, daily for 2 weeks</li> <li class="seamTextUnorderedListItem">Fitbit</li> <li class="seamTextUnorderedListItem">Sleep diary</li> <li class="seamTextUnorderedListItem">Surveys</li> <li class="seamTextUnorderedListItem">Interviews</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vagus nerve stimulation delivers low-intensity electrical currents in the inner ear to stimulate nerves that may improve sleep.</li> <li class="seamTextUnorderedListItem">Insomnia is difficulty falling asleep, staying asleep, or waking up too early.</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/NCT06006299' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/vagus-nerve-stimulation/about/pac-20384565' target='_blank'>Mayo Clinic: Vagus Nerve Stimulation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment-side-effects/insomnia#:~:text=Advertisement-,Insomnia%20can%20be%20caused%20by%20the%20stress%20of%20a%20breast,get%20a%20good%20night's%20sleep.' target='_blank'>Breastcancer.org: Insomnia and Breast Cancer</a> </li></ul>
2

Vagus Nerve Stimulator for Insomnia in People with Stage I-IV Breast Cancer

Investigating the Feasibility of Using taVNS to Treat Insomnia in Individuals With Stage I-IV Breast Cancer
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Nearest Location:
2011 miles
UAB Spain Rehabilitation Center
Birmingham, AL

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06006299

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Phase NA

3

Apollo Wearable Device to Reduce <span class="highlight">Fatigue</span> and Pain for People with Metastatic Breast Cancer

Apollo Device for <span class="highlight">Fatigue</span> in Metastatic Breast Cancer

Purpose: To study if the Apollo wearable device can reduce <span class="highlight">fatigue</span> and pain.

Who is this for?: Women with metastatic (stage IV) breast cancer who experience <span class="highlight">fatigue.</span> View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Apollo wearable device</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Apollo is a wearable device, similar to a FitBit, that emits vibrations.</li> <li class="seamTextUnorderedListItem">Apollo vibrations activate touch receptors in your skin that are perceived as safety signals by your brain to decrease stress and improve recovery, focus, and energy.</li> <li class="seamTextUnorderedListItem">Apollo is about the size of an Apple watch and can be worn on your ankle, wrist, or arm with two adjustable fabric straps.</li> <li class="seamTextUnorderedListItem">Fatigue is feeling tired.</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/NCT04983342' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://apolloneuro.com/' target='_blank'>Apollo Neuroscience: Apollo Device</a> </li></ul>
3

Apollo Wearable Device to Reduce <span class="highlight">Fatigue</span> and Pain for People with Metastatic Breast Cancer

Apollo Device for <span class="highlight">Fatigue</span> in Metastatic Breast Cancer
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Nearest Location:
2264 miles
Magee Womens Hospital
Pittsburgh, PA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04983342

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Phase NA

4

CKM Therapy with Pembrolizumab for Advanced Triple Negative Breast Cancer

Phase I/IIa Clinical Trial Evaluating the Safety and Efficacy of Rintatolimod Combined With IFNα2b (Bioferon®) to Enhance the Effectiveness of Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of chemokine modulation (CKM) therapy with pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer whose cancer progressed on prior treatment. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Rintatolimod (Ampligen®), by IV, 6 times within 2 weeks</li> <li class="seamTextUnorderedListItem">Celecoxib (Celebrex®), by mouth, 6 times within 2 weeks</li> <li class="seamTextUnorderedListItem">Interferon alpha 2b (Bioferon®), by IV, 6 times within 2 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">CT or MRI scans, 2 times</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemokine modulation (CKM) therapy is a type of immunotherapy that involves rintatolimod (Ampligen®), celecoxib (Celebrex®), and interferon alpha 2b (Bioferon®).</li> <li class="seamTextUnorderedListItem">Rintatolimod (Ampligen®) is a drug for chronic <span class="highlight">fatigue</span> syndrome that may also stimulate the immune system to fight cancer cells.</li> <li class="seamTextUnorderedListItem">Celecoxib (Celebrex®) is an anti-inflammatory drug that can cause cell death and may reduce the growth of blood vessels that tumors need to grow and spread.</li> <li class="seamTextUnorderedListItem">Interferon alpha 2b (Bioferon®) helps the immune system fight cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">CKM therapy may help pembrolizumab (Keytruda®) work better.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <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/NCT05756166' target='_blank'>ClinicalTrials.gov</a> </li></ul>
4

CKM Therapy with Pembrolizumab for Advanced Triple Negative Breast Cancer

Phase I/IIa Clinical Trial Evaluating the Safety and Efficacy of Rintatolimod Combined With IFNα2b (Bioferon®) to Enhance the Effectiveness of Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer
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Nearest Location:
2299 miles
Roswell Park Cancer Institute
Buffalo, NY

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Visits:
6 visits within 2 weeks, then 1 visit every 3 weeks

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ClinicalTrials.gov: NCT05756166

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Phase I-II

5

Studying <span class="highlight">Fatigue</span> in People with Stage I-IV Breast Cancer and Breast Cancer Survivors

Characterizing <span class="highlight">Fatigue</span> Experienced by Cancer Patients Receiving Primary Treatment and Cancer Survivors

Purpose: To understand how the immune system and body change during cancer treatment, how these changes cause <span class="highlight">fatigue,</span> and how quality of life is affected by <span class="highlight">fatigue.</span>

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are receiving treatment, or have recently completed standard treatment for primary breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will complete the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physical exam</li> <li class="seamTextUnorderedListItem">Questionnaires</li> <li class="seamTextUnorderedListItem">Physical activity tracking with wearable device</li> <li class="seamTextUnorderedListItem">Journaling</li> <li class="seamTextUnorderedListItem">Cognitive games (optional)</li> <li class="seamTextUnorderedListItem">Strength test (optional)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fatigue is a common side effect of cancer and treatment. Previous research has shown that <span class="highlight">fatigue</span> may be caused by a number of factors, including problems with the immune system response of the body while undergoing cancer treatment.</li> <li class="seamTextUnorderedListItem">A wearable device, such as a Fitbit, is device you wear that tracks your physical activity.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</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/NCT01231932' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment-side-effects/fatigue' target='_blank'>Breastcancer.org: Fatigue</a> </li></ul>
5

Studying <span class="highlight">Fatigue</span> in People with Stage I-IV Breast Cancer and Breast Cancer Survivors

Characterizing <span class="highlight">Fatigue</span> Experienced by Cancer Patients Receiving Primary Treatment and Cancer Survivors
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Nearest Location:
2433 miles
National Institutes of Health Clinical Center
Bethesda, MD

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Visits:
2-4 visits

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ClinicalTrials.gov: NCT01231932

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Phase NA

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