Baduanjin rehabilitation for recovery in immune therapy–related myocarditis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study is a randomized controlled trial enrolling adults who have recovered from ICI-associated myocarditis and are entering rehabilitation. Participants are assigned to receive either a structured rehabilitation regimen with Shengxian Quyu Decoction and Baduanjin-based exercise or standard care. The intervention lasts two weeks, with follow-up at four weeks to assess adherence, clinical status, lab results, symptom relief, quality of life, and major adverse cardiovascular events. The trial uses baseline assessments and a 2:1 follow-up window to monitor safety and potential benefits in this specific, post-acute setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* Diagnosis of fulminant myocarditis or cardiac function of NYHA IV.
* Clear evidence suggesting cardiac injury not attributable to ICIs.
* Concurrent acute cardiovascular events or malignant arrhythmias.
* Coexisting severe immune-related adverse events affecting other organ systems.
* Associated severe systemic diseases, such as severe hepatic or renal insufficiency, or severe infection.

Where it's running

• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Jingyi Ren, Professor — China-Japan Friendship Hospital
• Study coordinator: Chengcheng L, Dr
• Email: lcc77983@126.com
• Phone: 010-84206809

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.