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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

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>
3

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

4

Studying the Relationship Between Heart Rate Variability and <span class="highlight">Fatigue</span> During Treatment for Stage I-IV Breast Cancer

Wearable Activity Tracker Devices and Cancer-Related <span class="highlight">Fatigue:</span> A Clinical Utility Pilot Study For Patients Undergoing Anti-Cancer Treatment

Purpose: To study the relationship between heart rate variability (HRV) and <span class="highlight">fatigue</span> during cancer treatment.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are planning to receive or are receiving treatment. You must be experiencing <span class="highlight">fatigue</span> (tiredness). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Wear activity tracker device, 1 month</li> <li class="seamTextUnorderedListItem">Diary of activity tracker information, 1 month</li> <li class="seamTextUnorderedListItem">Surveys</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The activity tracker device measures your heart rate variability (HRV).</li> <li class="seamTextUnorderedListItem">Heart rate variability (HRV) is the fluctuations in the amount of time between your heartbeats.</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/NCT06291324' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/symptoms/21773-heart-rate-variability-hrv' target='_blank'>Cleveland Clinic: Heart Rate Variability</a> </li></ul>
4

Studying the Relationship Between Heart Rate Variability and <span class="highlight">Fatigue</span> During Treatment for Stage I-IV Breast Cancer

Wearable Activity Tracker Devices and Cancer-Related <span class="highlight">Fatigue:</span> A Clinical Utility Pilot Study For Patients Undergoing Anti-Cancer Treatment
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Nearest Location:
2300 miles
Levine Cancer Institute
Charlotte, NC

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Visits:
At least 3 visits within 1 month

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ClinicalTrials.gov: NCT06291324

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Phase NA

5

Fasting and/or Exercise to Reduce <span class="highlight">Fatigue</span> During Hormone Therapy for Women with Metastatic HR+ Breast Cancer

Prolonged Overnight Fasting And/or Exercise on <span class="highlight">Fatigue</span> and Other Patient Reported Outcomes in Women with Hormone Receptor Positive Advanced Breast Cancer (FastER)

Purpose: To study the ability of fasting and/or exercise to reduce <span class="highlight">fatigue</span> and improve other outcomes for women with advanced breast cancer who are receiving hormone therapy.

Who is this for?: Women with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+) breast cancer who are planning to receive treatment (starting within 1 month) with a CDK4/6 inhibitor as the first or second line of hormone therapy for metastatic disease. You must not exercise more than 1.5 hours/week or participate in regular structured fasting. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Fasting Alone</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fasting diet, daily for 3 months</li> <li class="seamTextUnorderedListItem">Complete food journal, daily for 3 months</li> <li class="seamTextUnorderedListItem">Heath coaching sessions, in-person or virtual, weekly for 3 months</li> <li class="seamTextUnorderedListItem">Blood and physical tests, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">PET and CT scans, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Exercise Alone</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Exercise program with health coach, in-person or virtual, 3 times every week for 3 months</li> <li class="seamTextUnorderedListItem">Wear FitBit, daily for 3 months</li> <li class="seamTextUnorderedListItem">Blood and physical tests, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">PET and CT scans, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Fasting and Exercise</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fasting diet, daily for 3 months</li> <li class="seamTextUnorderedListItem">Complete food journal, daily for 3 months</li> <li class="seamTextUnorderedListItem">Heath coaching sessions, in-person or virtual, weekly for 3 months</li> <li class="seamTextUnorderedListItem">Exercise program with health coach, in-person or virtual, 3 times every week for 3 months</li> <li class="seamTextUnorderedListItem">Wear FitBit, daily for 3 months</li> <li class="seamTextUnorderedListItem">Blood and physical tests, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">PET and CT scans, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4: No Fasting or Exercise</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">General health education sessions with health coach, virtual, every 2 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Wear FitBit, daily for 3 months</li> <li class="seamTextUnorderedListItem">Blood and physical tests, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">PET and CT scans, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">If you are in Group 1 or Group 3, you will be asked to fast (not eat or drink) after 8pm, and wait 12 to 14 hours before eating and drinking the next day. You will be asked to fast 6 nights every week (1 night off every week).</li> <li class="seamTextUnorderedListItem">If you are in Group 4, the sessions focus on general nutrition, healthy lifestyle, and quality of life, with no discussion of fasting or exercise. </li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</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/NCT06123988' target='_blank'>ClinicalTrials.gov</a> </li></ul>
5

Fasting and/or Exercise to Reduce <span class="highlight">Fatigue</span> During Hormone Therapy for Women with Metastatic HR+ Breast Cancer

Prolonged Overnight Fasting And/or Exercise on <span class="highlight">Fatigue</span> and Other Patient Reported Outcomes in Women with Hormone Receptor Positive Advanced Breast Cancer (FastER)
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Nearest Location:
2592 miles
University of Miami
Miami, FL

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Visits:
At least 4 visits within 1 year

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ClinicalTrials.gov: NCT06123988

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Phase NA

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