A Study of the TheraBionic P1 Device in Breast Cancer

Exclusion Criteria

• •Participants that are receiving or will receive neoadjuvant chemotherapy or neoadjuvant hormonal therapy
• •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
• •Participants with a known severe (e.g., anaphylactic) allergy to nickel.