The Efficacy of Oral Cryotherapy in Preventing TROP2-ADC-Induced Oral Mucositis in Patients With Advanced Breast Cancer: A Randomized, Controlled, Multicenter Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- The incidence and severity of oral mucositis within 8 weeks (scored according to the CECAE 5.0 standard)
研究概览
简要总结
The incidence of oral mucositis associated with TROP2-ADC therapy in patients with advanced breast cancer is notably high. Identifying effective preventive and therapeutic strategies is essential for enhancing patient quality of life and optimizing treatment outcomes. Oral cryotherapy has been demonstrated to be efficacious in mitigating oral mucositis induced by radiotherapy and chemotherapy. Consequently, this study seeks to investigate the potential preventive efficacy of oral cryotherapy on TROP2-ADC-induced oral mucositis in patients with advanced breast cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants voluntarily enrolled in the study, signed the informed consent form, and demonstrated good compliance.
- •Age ≥ 18 years at the time of informed consent signing.
- •Patients with locally advanced or recurrent/metastatic breast cancer receiving TROP2-ADC treatment for the first time.
- •ECOG PS: 0-2 points;
- •The expected survival time was more than 3 months;
- •Adequate organ and bone marrow function, with no transfusions or treatments with recombinant human thrombopoietin or colony-stimulating factors within 1 week before the first dose, is defined as follows:
- •Blood routine: Neutrophil count (NEUT#) ≥ 1.5×109/L; Platelet (PLT) ≥ 75×109/L; Hemoglobin ≥ 90g/L
- •Liver function: AST and ALT ≤ 3 × ULN; for patients with liver metastasis, AST and ALT ≤ 5 × ULN.
- •Renal function: Creatinine ≤ 1.5 × ULN or Ccr ≥ 60 ml/min (Cockcroft-Gault formula provided).
- •Cardiac function: LVEF ≥ 50% by ECHO or MUGA scan.
- •Patients with a negative pregnancy test and reproductive potential must agree to use effective non-hormonal contraception during treatment and for at least 3 months after the last dose of the investigational drug.
- •Voluntary participants who sign informed consent, demonstrate good compliance, and agree to follow-up.
排除标准
- •Prior TROP2-targeted treatment was administered.
- •Patients with active oral mucositis or oral ulcers were excluded.
- •Patients with serious concomitant diseases, as judged by researchers, that threaten safety or impede study completion, including uncontrolled hypertension, severe diabetes, and active infections, were excluded.
- •Other conditions where the investigator determines the patient is unsuitable for study participation.
研究组 & 干预措施
Oral cryotherapy
干预措施: Oral cryotherapy (Other)
Routine oral care
干预措施: Routine oral care (Other)
结局指标
主要结局
The incidence and severity of oral mucositis within 8 weeks (scored according to the CECAE 5.0 standard)
时间窗: From the start of TROP2-ADC treatment to the 8th week
The incidence and severity of oral mucositis at week 8
次要结局
- The incidence and severity of oral mucositis at week 12 and week 24(From the start of TROP2-ADC treatment to the 12th and 24th week)
- Progression-free survival(PFS)(Up to approximately 28 weeks)
- Treatment interruption rate(Up to approximately 28 weeks)