ICIAM Rehabilitation Program Study: A Randomized Controlled Trial

A Study on Rehabilitation Study for Immune Checkpoint Inhibitors-Associated Myocarditis: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Immune Checkpoint Inhibitors Related Myocarditis
• Intervention / Treatment: Other: rehabilitation protocol

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chengcheng L, Dr; Phone Number: 010-84206809; Email: lcc77983@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rehab Arm; The pharmacological rehabilitation protocol consists of oral administration of Shengxian Quyu Decoction. 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. The total treatment period is 2 weeks.	Other: rehabilitation protocol; 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.
No Intervention: Control Arm; The control arm received conventional treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	Cardiovascular Death, Cardiac Arrest, Cardiogenic Shock, High-Grade Atrioventricular Block	2 weeks
NT-proBNP/BNP levels	change in natriuretic peptide levels from baseline to Week 2	2 weeks
EQ-5D	Change in EQ-5D quality of life score	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	Rates of individual MACE components	2 and 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise adherence	Documenting patient exercise adherence	2 weeks

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital; Second Affiliated Hospital of Nanchang University; Weifang Hospital of Traditional Chinese Medicine
• Investigators: Principal Investigator: Jingyi Ren, Professor, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2023ZD0502805-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No