Plasma Treatment for Breast Cancer

Not yet recruiting at 1 trial location

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new breast cancer treatment involving non-thermal plasma (NTP), a special type of ionized gas. The goal is to determine if NTP is safe and effective when applied to the area where a breast tumor was removed. Researchers also aim to assess how the treatment affects the breast's appearance afterward. Ideal candidates are those diagnosed with breast cancer who plan to undergo a lumpectomy, without prior treatments like chemotherapy or radiation.

As an unphased trial, this study allows patients to contribute to groundbreaking research in breast cancer treatment.

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 prior data suggests that this non-thermal plasma treatment is safe for breast cancer patients?

Research shows that non-thermal plasma (NTP) treatments, such as the Convertible Plasma Jet, are being tested for safety in breast cancer patients. This study is the first to focus on how well breast cancer patients tolerate this treatment on the area where the tumor was removed after surgery.

Earlier research has found that gas plasma treatments can effectively target breast cancer cells and may help reduce tumor growth. However, since this is the first trial with breast cancer patients, information on safety and possible side effects remains limited.

These early studies aim to determine how much NTP can be safely used and how well patients handle the treatment. The goal is to find a dose that patients can tolerate without serious side effects. Participants will receive a one-time treatment, and researchers will closely monitor for any negative effects to ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Convertible Plasma Jet treatment for breast cancer because it introduces a novel method of using non-thermal plasma (NTP) technology. Unlike traditional treatments like surgery, chemotherapy, or radiation, which can have significant side effects and require a lengthy recovery, NTP offers a targeted approach that can be applied directly during surgery. This method may minimize damage to surrounding healthy tissues, potentially reducing side effects and enhancing recovery. By harnessing the unique properties of plasma, this treatment aims to provide a more precise and less invasive option for breast cancer patients.

What evidence suggests that this plasma treatment might be an effective treatment for breast cancer?

Research has shown that gas plasma treatments, such as the Convertible Plasma Jet, can effectively kill breast cancer cells and reduce tumor growth. This trial will investigate the Convertible Plasma Jet as an experimental treatment, with patients receiving NTP treatment intra-operatively. This technology uses a special type of gas to target cancer cells. Lab studies have demonstrated that this gas damages cancer cells while leaving healthy cells unharmed, suggesting it could be a promising tool for treating breast cancer. Early patient studies focus on determining the safe dose and monitoring side effects. Researchers hope this treatment might help prevent cancer from returning after surgery. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: NTP treatment Experimental Treatment 1 Intervention

The patients will be treated with NTP intra-operatively.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Ozmosis Research Inc.

Industry Sponsor

Trials

25

Recruited

5,200+

Ministère de l'Économie, de l'Innovation et de l'Énergie, Québec, Canada

Collaborator

Trials

1

Recruited

30+

Quebec Breast Cancer Foundation

Collaborator

Trials

7

Recruited

890+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12013180/

Breast cancer PAINT: a first-in-human, dose-escalation study ... This is the first clinical trial to study the safety and tolerability of NTP in an all-breast cancer patient cohort.

2. withpower.com withpower.com/trial/phase-breast-cancer-2024-4e48a

Plasma Treatment for Breast Cancer · Info for Participants Research shows that gas plasma treatments, like the Convertible Plasma Jet, can effectively kill breast cancer cells and reduce tumor growth, similar to ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06222788

Breast Cancer Plasma Adjuvant Intra-operative Treatment ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9394754/

The potential of gas plasma technology for targeting breast ... This work outlines the assets of gas plasma technology as a novel tool for targeting breast cancer by summarizing the action of plasma devices.

5. pubs.aip.org pubs.aip.org/aip/acp/article/2922/1/040004/3265297/The-effect-of-plasma-jet-on-total-superoxide

The effect of plasma jet on total superoxide dismutase ... The present study was focused on their effect on breast cancer antioxidant enzyme (TSOD) and tumor derived-IgG. First, the effect of PAM on ...

6. researchgate.net researchgate.net/publication/391019117_Breast_cancer_PAINT_a_first-in-human_dose-escalation_study_to_determine_the_safety_of_Plasma_Adjuvant_INtra-operative_Treatment_in_breast_cancer_patients

(PDF) Breast cancer PAINT: a first-in-human, dose ... This is the first clinical trial to study the safety and tolerability of NTP in an all-breast cancer patient cohort.

7. ancora.ai ancora.ai/fr/details/NCT06222788

Breast Cancer Plasma Adjuvant Intra-operative Treatment ... 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 ...