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ICIAM Rehabilitation Program Study: A Randomized Controlled Trial

NCT07280429 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-12

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Weifang Hospital of Traditional Chinese Medicine

    collaborator UNKNOWN

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    collaborator OTHER

  • Second Affiliated Hospital of Nanchang University

    collaborator OTHER

  • China-Japan Friendship Hospital

    lead OTHER

Principal Investigators

  • Jingyi Ren, Professor · China-Japan Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-07-31
Completion
2028-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07280429 on ClinicalTrials.gov