Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2026-10-31
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TheraBionic P1 device
Self Administered Amplitude-modulated electromagnetic fields three times daily
TheraBionic P1 Device
Amplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three 60-minute treatments per day, administered in the morning, middle of the day and in the evening prior to surgical resection of early stage breast cancer.
Interventions
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TheraBionic P1 Device
Amplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three 60-minute treatments per day, administered in the morning, middle of the day and in the evening prior to surgical resection of early stage breast cancer.
Eligibility Criteria
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Inclusion Criteria
* Participant must have early-stage operable disease (stage I-II or III who have planned upfront surgery) and agree to definitive upfront surgery.
* Participant must be available for at least two weeks of TheraBionic treatment prior to scheduled resection
* Participant must have archival tissue available.
* Participant must be a woman aged 22 years or older
* Participant must be able to understand a written informed consent document and be willing to sign it
* Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* It is not known what effects this treatment has on human pregnancy or development of the embryo or fetus. Therefore, women of child-bearing potential must agree to avoid becoming pregnant starting at initiation of treatment up until at least 30 days after the last TheraBionic P1 session
Exclusion Criteria
* Participants with known active secondary malignancy, unless, in the opinion of the investigator, it is unlikely to interfere with the safety and efficacy of the endpoints
* Participants that are taking any other investigational drugs
* Participants that are pregnant or breastfeeding due to the unknown but potential risk for adverse events. If a breastfeeding participant would like to be part of this study, breastfeeding must be discontinued
* Participants with active oral mucosal inflammation, ulceration, or other pathology that could interfere with the use of TheraBionic P1 device (for example: mucositis, thrush, bleeding mucosal lesions, oral herpes, aphthous stomatitis, mouth ulcers, chancre sores, gingivostomatitis, herpangina, aphthae).
* Participants receiving calcium channel blockers and any agent blocking L-type or T-type voltage gated calcium channels (for example: amlodipine, nifedipine, ethosuximide, ascorbic acid/vitamin C, etc.) unless their medical treatment is discontinued at least one day prior to treatment. Participant must agree to abstain from using calcium channel blockers for the duration of treatment on study.
* Participants that do not agree to be followed according to the study protocol or have cognitive or physical inability to use the device
22 Years
FEMALE
No
Sponsors
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Barbara Ann Karmanos Cancer Institute
OTHER
Responsible Party
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Lubina Arjyal MD
Principal Investigator
Principal Investigators
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Lubina Arjyal, M.D.
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
Locations
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Karmanos Cancer Institute
Detroit, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Lubina Arjyal, MD
Role: primary
Other Identifiers
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2025-026
Identifier Type: -
Identifier Source: org_study_id