Baduanjin Rehabilitation for Functional Restoration in ICI-Associated Myocarditis
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07280429, who can take part
Where in China
- China-Japan Friendship HospitalBeijing, ChinaContact: Chengcheng L, DrTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- China-Japan Friendship Hospital
- Trial code
- NCT07280429
- Record updated
- 5 November 2026
- Original description
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.Read full original descriptionShow less
Individualized Symptom-Limited Baduanjin Exercise for Functional Recovery in Patients Recovering From Immune Checkpoint Inhibitor-Associated Myocarditis: The B-RESTORE-ICIAM Study
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.
Inclusion: Aged 18 to 80 years, inclusive; Malignancy confirmed by cytology or histopathology; Diagnosis of ICIAM following ICI therapy; Assessed by the Multidisciplinary Team for Immune-Related Adverse Events as clinically recovered and entering the rehabilitation; Meet TCM syndrome differentiation criteria for "Yangqi Deficiency with Internal Retention of Phlegm and Stasis."; KPS score > 60, with a life expectancy > 6 months.
Exclusion: Concurrent acute cardiovascular events or malignant arrhythmias; Diagnosis of fulminant myocarditis or cardiac function of NYHA IV; Clear evidence suggesting cardiac injury not attributable to ICIs; Associated severe systemic diseases, such as severe hepatic or renal insufficiency, or severe infection; Coexisting severe immune-related adverse events affecting other organ systems.