Breast cancer: applying non-thermal plasma after tumor removal to see if it is safe and tolerable

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study explores the safety and tolerability of a single intraoperative non-thermal plasma treatment applied to the tumor bed after lumpectomy in breast cancer patients. Participants are assigned to three groups in a 3+3 design to evaluate escalating doses and treatment locations, including ex vivo and in situ approaches. Patients are followed for three months, with safety monitored through adverse events, dose-limiting toxicities, and physical exams, plus exploratory assessment of effects on tissue. The study aims to identify a safe dose, monitor potential side effects, and observe any cosmetic impact of the treatment. The trial is conducted at CHUM in Montreal with collaboration from Ozmosis Research and the Quebec Breast Cancer Foundation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years at the time of signing study consent.
2. ECOG ≤2.
3. Patient with T1-4 breast cancer for groups A and B; patient with T1/T2 breast cancer for group C (based on physical exam, not radiological measurements).
4. Patient is scheduled to undergo a lumpectomy.

Exclusion Criteria:

1. Prior treatment for the tumor of interest (including chemotherapy, immunotherapy, radiotherapy).
2. Patient planning to or undergoing intraoperative radiotherapy.
3. Diabetes (types I and II).
4. Hypercortisolism.
5. Collagen vascular disease.
6. Patient requiring systemic corticosteroids at physiologic doses exceeding 10 mg/day of prednisone or its equivalent.
7. Patient receiving daily chemotherapy for rheumatological conditions.
8. Pregnancy (a urine pregnancy test must be obtained for non-sterile women of childbearing potential prior to surgery).

Where it's running

• Centre Hospitalier de l'Université de Montréal - CHUM
  Montreal, Quebec, Canada Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.