Glory Audrey, Patocskai Erica, Wong Philip
Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada.
Département de chirurgie, Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada.
BMC Cancer. 2025 Apr 22;25(1):748. doi: 10.1186/s12885-025-14153-5.
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.
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).
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.
Name of the registry: ClinicalTrials.gov.
NCT06222788. Date of registration: 01/15/2024. URL of trial registry record: https://clinicaltrials.gov/study/NCT06222788 .
非热等离子体（NTP）是指由离子、电子和其他反应剂组成的电离气体。NTP的抗癌特性已在体外和体内得到证实。乳腺癌患者保乳治疗（即肿块切除术，通常随后进行放射治疗）后的10年局部复发风险（LRR）仍高达15% - 20%。NTP可用于进一步治疗肿瘤床以降低LRR。
我们的主要目标是确定乳腺癌肿块切除术后NTP治疗的安全且可耐受剂量。次要目标是评估NTP的安全性和耐受性，并评估NTP治疗对乳腺癌患者的美容效果。探索性目标是评估NTP治疗对癌组织和正常组织的影响。NTP治疗后对患者进行长达3个月的随访。患者分为3组：A组（n = 3）：对部分肿瘤床进行体外NTP治疗。B组（n = 3）：对部分肿瘤床进行原位NTP治疗（所有治疗组织均切除用于分析）。C组（n = 6 - 24）：按照“3 + 3设计”进行剂量递增，最高剂量水平为3。对部分肿瘤床进行原位NTP治疗（肿瘤床的治疗部分除一小部分用于分析外不会切除）。
将通过剂量限制毒性、不良事件（AE）和严重不良事件报告、体格检查以及实验室安全性评估来评估治疗的安全性和耐受性。AE将根据CTCAE v5.0进行编码。结果将列表以检查其频率、分级以及与研究治疗的关系。实验室评估结果将进行类似评估。将通过生活质量问卷（关于乳房外观和质地的问题）以及照片收集来评估与NTP治疗相关的美容改变患者数量和改变类型。这是第一项研究NTP在所有乳腺癌患者队列中的安全性和耐受性的临床试验。
注册机构名称：ClinicalTrials.gov。
NCT06222788。注册日期：2024年1月15日。试验注册记录的网址：https://clinicaltrials.gov/study/NCT06222788 。
