ICIAM Rehabilitation Program Study: A Randomized Controlled Trial

NCT07280429 | Not Yet Recruiting DMC

• 1 other identifier: 2023ZD0502805-02
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Immune Checkpoint Inhibitors Related Myocarditis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• MACE

  2 and 4 weeks

Other Outcomes (1)

• Exercise adherence

  2 weeks

Study Arms (2)

Rehab Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

The control arm received conventional treatment.

Interventions

rehabilitation protocol OTHER

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.

Rehab Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead
• Weifang Hospital of Traditional Chinese Medicine: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator

Study Officials

• Jingyi Ren, Professor

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chengcheng L, Dr

CONTACT

010-84206809; lcc77983@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of medicine(Cardiology), Deputy Director of the Cardiology Department and Director of the Heart Failure Center

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share