Immune Checkpoint Inhibitors Related Myocarditis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
The intervention protocol comprised a pharmacological component (Shengxian Quyu therapy) and a traditional Chinese exercise rehabilitation component.The traditional Chinese exercise rehabilitation protocol is designed following the FITT (Frequency, Intensity, Time, Type) principles of exercise therapy. Exercise modalities may include Baduanjin, with specific frequency, duration, and intensity tailored to each participant's actual condition.
Sponsors
Weifang Hospital of Traditional Chinese Medicine
Chinese Academy of Medical Sciences, Fuwai Hospital
Second Affiliated Hospital of Nanchang University
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 2 weeks | Cardiovascular Death, Cardiac Arrest, Cardiogenic Shock, High-Grade Atrioventricular Block |
| NT-proBNP/BNP levels | 2 weeks | change in natriuretic peptide levels from baseline to Week 2 |
| EQ-5D | 2 weeks | Change in EQ-5D quality of life score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 2 and 4 weeks | Rates of individual MACE components |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exercise adherence | 2 weeks | Documenting patient exercise adherence |
Contacts
Primary ContactChengcheng L, Dr
Outcome results
None listed