Plasma Treatment for Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must not be taking: Systemic corticosteroids, Chemotherapy

Disqualifiers: Diabetes, Hypercortisolism, Collagen vascular disease, others

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

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids over 10 mg/day or daily chemotherapy for rheumatological conditions, you may not be eligible to participate.

What data supports the effectiveness of the Convertible Plasma Jet treatment for breast cancer?

Research shows that gas plasma treatments, like the Convertible Plasma Jet, can effectively kill breast cancer cells and reduce tumor growth, similar to chemotherapy. These treatments work by creating reactive oxygen and nitrogen species that damage cancer cells and boost the body's immune response against tumors.¹ ² ³ ⁴ ⁵

How does plasma treatment for breast cancer differ from other treatments?

The plasma treatment for breast cancer is unique because it potentially offers a novel approach compared to traditional radiation therapies like whole breast irradiation (WBI) or accelerated partial breast irradiation (APBI), which focus on delivering radiation to specific areas of the breast. Plasma treatment may involve a different mechanism or method of administration, but specific details are not provided in the available research.⁶ ⁷ ⁸ ⁹ ¹⁰

What is the purpose of this trial?

The goal of this clinical trial is to test the safety of the use of non-thermal plasma (NTP, an ionized gas) on the tumor bed after the removal of the tumor in breast cancer patients. The main questions it aims to answer are:* To determine the safe and tolerable dose of NTP in patients with breast cancer;* To assess the safety and tolerability of NTP;* To assess the cosmetic effects of NTP treatment in patients with breast cancer. Participants will receive one treatment of the tumor bed after the removal of their breast tumor.

Eligibility Criteria

This trial is for breast cancer patients who have had their tumor surgically removed. It's designed to find out the safest dose of a new treatment using non-thermal plasma on the area where the tumor was. Participants will receive this treatment once post-surgery.

Inclusion Criteria

I am scheduled for a lumpectomy.

My breast cancer is in an early to advanced stage, but not based on scans.

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

I have a collagen vascular disease.

Pregnancy (a urine pregnancy test must be obtained for non-sterile women of childbearing potential prior to surgery)

I take more than 10 mg/day of prednisone or its equivalent.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intra-operative treatment of the tumor bed with non-thermal plasma (NTP) after tumor removal

1 day

1 visit (in-person, intra-operative)

Follow-up

Participants are monitored for safety, tolerability, and cosmetic effects of NTP treatment

3 months

Multiple visits for assessments and questionnaires

Long-term follow-up

Participants are monitored for evidence of cancer cell death and effects on normal tissue

15 months

Treatment Details

Interventions

Convertible Plasma Jet

Trial Overview The study is testing a device called Convertible Plasma Jet, which applies non-thermal plasma directly to the site of tumor removal in breast cancer patients. The aim is to determine safe dosage and evaluate both safety and cosmetic outcomes.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: NTP treatmentExperimental Treatment1 Intervention

The patients will be treated with NTP intra-operatively.