Breast cancer PAINT - a first-in-human, dose-escalation study to determine the safety of Plasma Adjuvant INtra-operative Treatment in breast cancer patients - Study protocol

Sep 23, 2026

Uploaded by Connor

Non-thermal plasma (NTP) is an ionized gas containing reactive agents with anticancer activity demonstrated in vitro and in vivo. Despite breast conservation therapy, 10-year local recurrence risk remains 15–20%, motivating evaluation of NTP to treat the tumor bed and potentially reduce recurrence. The protocol targets safe, tolerable dosing after lumpectomy, assesses adverse events, serious events, laboratory safety, and cosmetic outcomes over up to 3 months after treatment.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages10

Reading Time25 min

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Abstract

Background

Methods

Discussion

Trial registration

Glory et al. BMC Cancer (2025) 25:748 BMC Cancer [https://doi.org/10.1186/s12885-025-14153-5](https://doi.org/10.1186/s12885-025-14153-5) STUDY PROTOCOL Open Access Breast cancer PAINT: a first-in-human, dose- escalation study to determine the safety of Plasma Adjuvant INtra-operative Treatment in breast cancer patients Audrey Glory 1, Erica Patocskai 1,2 and Philip Wong 1,3,4* Abstract Background Non-thermal plasma (NTP) refers to an ionized gas composed of ions, electrons and other reactive agents. The anticancer properties of NTP have been proven in vitro and in vivo. The 10-year local recurrence risk (LRR) in breast cancer patients after breast conservation therapy (i. e., lumpectomy, typically followed by radiation therapy) is still as high as 15–20% . NTP could be used to further treat the tumor bed to reduce the LRR. Methods Our primary objective is to determine the safe and tolerable dose of NTP treatment following breast cancer lumpectomy. Our secondary objectives are to assess the safety and tolerability of NTP and to assess the cosmetic effects of NTP treatment in patients with breast cancer. Our exploratory objective is to assess the impact of NTP treatment on cancerous and normal tissues. Patients are followed for up to 3 months after NTP treatment. The patients are divided into 3 groups: group A (n = 3): NTP treatment of part of the tumor bed ex vivo. Group B (n = 3): NTP treatment of part of the tumor bed in situ (all treated tissues are removed for analysis) . Group C (n = 6–24): dose escalation per“3 + 3 Design” up to a maximum dose level of 3. NTP treatment of part of the tumor bed in situ (the treated parts of the tumor bed will not be excised, except for a small portion for analysis) . Discussion The safety and tolerability of treatment will be evaluated by means of dose-limiting toxicity, adverse event (AE) and serious adverse event reports; physical examinations; and laboratory safety evaluations. AEs will be coded according to CTCAE v5 .0. The results will be tabulated to examine their frequency, grade, and relationship to the study treatment. The results of laboratory assessments will be evaluated similarly. The number of patients with cosmetic alterations linked to NTP treatment and the type of alteration will be assessed through quality of life questionnaires (questions about breast appearance and texture) and through photo collection. This is the first clinical trial to study the safety and tolerability of NTP in an all-breast cancer patient cohort. Trial registration Name of the [registry: ClinicalTrials.gov. Trial](registry: ClinicalTrials.gov. Trial) registration number: NCT06222788 . Date of registration: 01/15/2024 . URL of trial registry record: [https://clinicaltrials.gov/study/NCT06222788](https://clinicaltrials.gov/study/NCT06222788) . Keywords Non-thermal plasma, Breast cancer, Intraoperative treatment, Local recurrence risk *Correspondence: Philip Wong [philip.wong4@uhn.ca](philip.wong4@uhn.ca) Full list of author information is available at the end of the article © The Author(s) 2025. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit [http://creativecommons.org/l](http://creativecommons.org/l)icenses/by/4.0/. Glory e

FAQs

What is the main purpose of the Breast cancer PAINT study?

To determine the safe and tolerable dose of non-thermal plasma (NTP) treatment following breast cancer lumpectomy.

How are participants assigned to treatment groups?

Patients are divided into three groups: group A receives ex vivo NTP on part of the tumor bed (n=3), group B receives in situ NTP with excised tissues removed for analysis (n=3), and group C undergoes dose escalation using a “3 + 3 Design” (n=6–24).

How will safety and tolerability be evaluated?

Safety will be assessed using dose-limiting toxicity, adverse events and serious adverse events, physical examinations, and laboratory safety evaluations, with adverse events coded per CTCAE v5.0.

Sep 23, 2026

Uploaded by Connor