A Study of the TheraBionic P1 Device in Breast Cancer

Purpose

The goal of this clinical trial is to learn if adding cancer-specific amplitude-modulated radiofrequency electromagnetic field therapy (TheraBionic P1 device) to the treatment of resectable early-stage breast cancer will affect the pathological response.

Conditions

  • Breast Cancer Stage I
  • Breast Cancer Stage II
  • Breast Cancer Stage IIIA
  • Hormone Receptor Positive Tumor
  • HER2-negative Breast Cancer

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participant must have histologically proven invasive breast cancer that is HR (hormone receptor) positive and HER2 (Human Epidermal Growth Factor Receptor 2) negative according to the 2010 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (ER and/or PR (progesterone receptor) >1% and HER2 negative by immunohistochemistry [IHC] and/or fluorescent in situ hybridization [FISH]). - 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 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TheraBionic P1 device 		Self Administered Amplitude-modulated electromagnetic fields three times daily
  • Device: 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.

Recruiting Locations

Karmanos Cancer Institute at McLaren Clarkston
Clarkston, Michigan 48346
Contact:
248-922-6650

Karmanos Cancer Institute
Detroit, Michigan 48201
Contact:
Lubina Arjyal, MD
1-800-527-6266
arjyall@karmanos.org

Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
Contact:
1-800-527-6266

Karmanos Cancer Institute at McLaren Flint
Flint, Michigan 48532
Contact:
810-342-3800

Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan 48910
Contact:
517-975-9500

Karmanos Cancer Institute at McLaren Lapeer Region
Lapeer, Michigan 48466
Contact:
810-667-4994

Karmanos Cancer Institute at McLaren Northern Michigan
Petoskey, Michigan 49770
Contact:
231-487-3390

Karmanos Cancer Institute at McLaren Port Huron
Port Huron, Michigan 48060
Contact:
810-982-5200

More Details

Status
Recruiting
Sponsor
Barbara Ann Karmanos Cancer Institute

Study Contact

Lubina Arjyal, M.D.
1-800-karmanos
arjyall@karmanos.org