A Study on Rehabilitation Study for Immune Checkpoint Inhibitors-Associated Myocarditis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- MACE
研究概览
简要总结
Immunotherapy has become a cornerstone in oncology; however, managing its associated adverse events poses a significant clinical challenge. Cardiotoxicity represents a major concern, among which myocarditis accounts for a considerable proportion. This condition is characterized by poor prognosis, highly heterogeneous outcomes, and a high prevalence of persistent cardiac dysfunction after the acute phase. The dual impact of myocardial injury and underlying malignancy severely compromises patients' quality of life. Currently, it remains unclear whether implementing rehabilitation strategies for this patient population can mitigate the aforementioned challenges. Therefore, we designed a randomized controlled trial to evaluate the efficacy and safety of a structured rehabilitation program for convalescent patients with ICIAM.
详细描述
Eligible patients who are suitable for rehabilitation therapy and meet the TCM syndrome differentiation criteria of "Yangqi Deficiency with Internal Retention of Phlegm and Stasis" will be screened and undergo baseline assessments. Subsequently, they will be randomly assigned in a 1:1 ratio using block randomization to either the experimental group or the control group. The experimental group will receive a rehabilitation regimen consisting of Shengxian Quyu Decoction and specialized traditional Chinese exercise therapy, while the control group will receive conventional treatment only.The pharmacological rehabilitation intervention for the experimental group involves oral administration of Shengxian Quyu Decoction. The traditional exercise regimen is designed in accordance with the FITT principle (Frequency, Intensity, Time, Type) of exercise rehabilitation. Exercise modalities may include Baduanjin, with specific frequency, duration, and intensity tailored to individual patient conditions.The total rehabilitation period is 2 weeks. A follow-up assessment will be conducted at the end of the second week to document exercise adherence and evaluate physical examination findings, laboratory test results, TCM syndrome scores, quality of life, and Major Adverse Cardiovascular Events (MACE). Extended follow-up will continue through week 4 for MACE assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •①Aged 18 to 80 years, inclusive.②Malignancy confirmed by cytology or histopathology.③Diagnosis of ICIAM following ICI therapy.④Assessed by the Multidisciplinary Team for Immune-Related Adverse Events as clinically recovered and entering the rehabilitation.⑤Meet TCM syndrome differentiation criteria for "Yangqi Deficiency with Internal Retention of Phlegm and Stasis."⑥ KPS score > 60, with a life expectancy > 6 months.
排除标准
- •①Diagnosis of fulminant myocarditis or cardiac function of NYHA IV.②Clear evidence suggesting cardiac injury not attributable to ICIs.③Concurrent acute cardiovascular events or malignant arrhythmias.④Coexisting severe immune-related adverse events affecting other organ systems.⑤Associated severe systemic diseases, such as severe hepatic or renal insufficiency, or severe infection.
结局指标
主要结局
MACE
时间窗: 2 weeks
Cardiovascular Death, Cardiac Arrest, Cardiogenic Shock, High-Grade Atrioventricular Block
NT-proBNP/BNP levels
时间窗: 2 weeks
change in natriuretic peptide levels from baseline to Week 2
EQ-5D
时间窗: 2 weeks
Change in EQ-5D quality of life score
次要结局
- MACE(2 and 4 weeks)
研究者
Jingyi Ren
Professor of medicine(Cardiology), Deputy Director of the Cardiology Department and Director of the Heart Failure Center
China-Japan Friendship Hospital