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Efficacy and Safety of Shexiang Tongxin Dropping Pills in the Treatment of Anthracycline-Induced Cardiotoxicity (Qi Deficiency and Blood Stasis Syndrome) in Cancer Patients: Study Protocol for A Randomized Double-Blind Placebo-Controlled Multicenter Clinical Trial

Efficacy and Safety of Shexiang Tongxin Dropping Pills in the Treatment of Anthracycline-Induced Cardiotoxicity (Qi Deficiency and Blood Stasis Syndrome) in Cancer Patients: Study Protocol for A Randomized Double-Blind Placebo-Controlled Multicenter Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001066
Enrollment
Unknown
Registered
2025-05-28
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anthracycline-induced cardiotoxicity

Interventions

control group:Western standardized therapy + Shexiang Tongxin Dropping Pills placebo
experimental group:Standardized Western medical treatment + Shexiang Tongxin Dropping Pills

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-75 years; (2) Patients with breast cancer or malignant lymphoma receiving first-line chemotherapy with anthracycline-containing agents; (3) Elevated baseline troponin I (cTnI) above the 99th percentile of the upper reference value; (4) Those diagnosed with Qi deficiency and blood stasis by Chinese medicine evidence; (5) Voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: (1) Acute coronary syndrome cardiogenic shock uncontrollable severe arrhythmia acute pulmonary embolism hypertensive crisis; (2) With serious complications related to the primary tumor even life-threatening; (3) Have a history of cerebrovascular gastrointestinal respiratory urinary tract or other organ bleeding within 1 month; (4) Suffering from serious mental illness; (5) Hypersensitivity to components of the study drug; (6) Serious infection; (7) Pregnancy or lactation; (8) Unexplained persistent elevation of aminotransferases (greater than 3 times the upper limit of normal); (9) Renal failure: estimated glomerular filtration rate <45 mL/min/1.73 m2; (10) Participation in other clinical trials within the last 1 month.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with normalized cTnI at 3 weeks of treatment;—

Secondary

MeasureTime frame
Cancer treatment-related cardiac dysfunction;Chinese Medicine Score;Incidence of MACEs;Cardiac Ultrasound Indicators;Ambulatory electrocardiogram;Cardiac Marker Levels;—

Countries

China

Contacts

Public ContactRong Li

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

13798184933@126.com13798184933

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026