TheraBionic P1 Device for Breast Cancer

Overseen By Lubina Arjyal, M.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Barbara Ann Karmanos Cancer Institute

Must not be taking: Investigational drugs, Calcium channel blockers

Disqualifiers: Neoadjuvant therapy, Active malignancy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the TheraBionic P1 device, which emits specialized radiofrequency waves, can improve treatment outcomes for early-stage breast cancer that can be surgically removed. The researchers aim to understand how this device affects cancer when added to standard treatment. Women with hormone receptor-positive, HER2-negative breast cancer preparing for surgery might find this trial suitable. Participants should use the device three times daily for at least two weeks before surgery. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future treatment options.

Will I have to stop taking my current medications?

If you are taking calcium channel blockers (medications for blood pressure or heart conditions), you will need to stop at least one day before starting the trial and avoid them during the study. For other medications, the trial protocol does not specify, so it's best to discuss with the trial team.

What prior data suggests that the TheraBionic P1 device is safe for breast cancer treatment?

Previous studies have shown that the TheraBionic P1 device is well tolerated. Research indicates that the device is easy to use and poses a low risk. In patients with metastatic breast cancer, reports indicate it shrinks tumors without significant side effects. Another study involving patients with advanced liver cancer found the device well tolerated, even among those with serious health issues. No major safety concerns have been reported so far. However, the device has not yet been tested in individuals under 18. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The TheraBionic P1 Device is unique because it uses amplitude-modulated electromagnetic fields to target breast cancer cells. Unlike traditional treatments like chemotherapy and radiation, which can affect both healthy and cancerous cells, this device offers a non-invasive approach that aims to minimize damage to healthy tissues. Researchers are excited because this method has the potential to be self-administered at home, providing convenience and reducing the need for frequent hospital visits.

What evidence suggests that the TheraBionic P1 device is effective for breast cancer?

Research has shown that the TheraBionic P1 device, which uses special radio waves, may help treat breast cancer. In earlier studies, 34.1% of patients had their disease remain stable for more than six months, meeting the study's main goal of having at least 8 patients with stable conditions. Other research has found that the device can shrink tumors and stop new cancer cells from growing. While the device is approved in Europe for treating liver cancer, early results for breast cancer are promising. Participants in this trial will use the TheraBionic P1 device, which is self-administered three times daily. ^{2 3 6 7 8}

Who Is on the Research Team?

Lubina Arjyal, M.D.

Principal Investigator

Wayne State University

Are You a Good Fit for This Trial?

This trial is for women aged 22 or older with early-stage, operable breast cancer that's HR positive and HER2 negative. They must not be pregnant, agree to avoid pregnancy during the study, have an ECOG status of 0-2, understand and sign consent forms, and commit to two weeks of treatment before surgery without taking certain drugs like calcium channel blockers.

Inclusion Criteria

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

I can care for myself and am up and about more than 50% of my waking hours.

Participant must be able to understand a written informed consent document and be willing to sign it

Exclusion Criteria

Participants that are taking any other investigational drugs

I am not taking calcium channel blockers, or I can stop them before treatment.

I am undergoing or will undergo initial treatment with chemotherapy or hormonal therapy before surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive cancer-specific amplitude-modulated radiofrequency electromagnetic field therapy using the TheraBionic P1 device three times daily

2 weeks

Surgery

Tumor resection surgery is performed to assess pathological response

1 day

Follow-up

Participants are monitored for progression-free survival and overall survival, with assessments every six months post-surgery

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• TheraBionic P1 Device

Trial Overview The TheraBionic P1 device is being tested in this study. It uses a specific type of electromagnetic field therapy added to standard treatment for early-stage breast cancer. The aim is to see if it improves the response when used before surgical resection.

How Is the Trial Designed?

Group I: TheraBionic P1 device Experimental Treatment 1 Intervention

Self Administered Amplitude-modulated electromagnetic fields three times daily

Who Is Running the Clinical Trial?

Barbara Ann Karmanos Cancer Institute

Lead Sponsor

Trials

166

Recruited

9,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07218432

A Study of the TheraBionic P1 Device in Breast Cancer The goal of this clinical trial is to learn if adding cancer-specific amplitude-modulated radiofrequency electromagnetic field therapy ...

2. therabionic.de therabionic.de/therapy-with-the-therabionic-p1-medical-device/

Therapy with the TheraBionic P1 Of the 41 patients, 14 patients (34.1%) had stable disease (SD) for more than 6 months, which met the preplanned primary efficacy criterion of 8 patients ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6604768/

Ca2+ and CACNA1H mediate targeted suppression of breast ... In July 2018, the TheraBionic P1 medical device emitting hepatocellular carcinoma-specific AM RF EMF received European regulatory approval as a class IIa, low ...

4. karmanos.org karmanos.org/karmanos-foundation/news/5402

Karmanos Foundation News Multiple studies over two decades have shown using the TheraBionic P1 device resulted in tumor shrinkage, blocked new cancer cell growth, and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352396419303421

Tumour-specific amplitude-modulated radiofrequency ... This study shows that intrabuccally-delivered AM RF EMF result in whole-body absorption below international standards for safety exposure.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/H220001B.pdf

Summary of Safety and Probable Benefit (SSPB) The TheraBionic P1 may not be used by patients younger than 18 years as it has not yet been tested in such patients. • The Therabionic P1 should not be ...

7. researchgate.net researchgate.net/publication/353408887_Safety_and_Efficacy_of_amplitude-modulated_radiofrequency_electromagnetic_fields_in_advanced_hepatocellular_carcinoma

(PDF) Safety and Efficacy of amplitude-modulated ... Conclusions and Relevance : Treatment of advanced HCC with the TheraBionic P1 device is well tolerated, even in patients with severely impaired ...

8. fda.gov fda.gov/medical-devices/recently-approved-devices/therabionic-p1-h220001

TheraBionic P1 – H220001 In a clinical trial of 41 adults, 14 patients (34.1%) had stable disease for more than 6 months. When should it not be used? The device should ...