A Study of the TheraBionic P1 Device in Breast Cancer

Part of paid clinical trials in Clarkston, Michigan.

Sponsor
Barbara Ann Karmanos Cancer Institute
Study ID
NCT07218432
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TheraBionic P1 Device — 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.

Study Details

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.

Key Dates

Start date
Oct 31, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Pathological Response to Treatment [ Time Frame: At time of surgery (after approximately 2 weeks of treatment and tumor resection) ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Karmanos Cancer Institute at McLaren ClarkstonClarkstonMichigan48346
248-922-6650
Karmanos Cancer InstituteDetroitMichigan48201
Lubina Arjyal, MD
1-800-527-6266
Karmanos Cancer Institute Weisberg Cancer Treatment CenterFarmington HillsMichigan48334
1-800-527-6266
Karmanos Cancer Institute at McLaren FlintFlintMichigan48532
810-342-3800
Karmanos Cancer Institute at McLaren Greater LansingLansingMichigan48910
517-975-9500
Karmanos Cancer Institute at McLaren Lapeer RegionLapeerMichigan48466
810-667-4994
Karmanos Cancer Institute at McLaren Northern MichiganPetoskeyMichigan49770
231-487-3390
Karmanos Cancer Institute at McLaren Port HuronPort HuronMichigan48060
810-982-5200

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