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Clinical Trials in China / NCT06881550
Enrolling by invitation Not applicable

Real-world Study on Shenbailing Granules for Improving Qi and Blood Deficiency in Patients After Breast Cancer Surgery

NCT06881550 · tracked via the Priya Life Science China tracker
Sponsor
Caigang Liu
Phase
Not applicable
Started
2024-12-30
Last updated
2025-03-18

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Shenbailing

Shenbailing: Adjuvant therapy with Shenbailing granules, starting from 1 day after surgery.

Study summary

This study aims to explore the clinical efficacy of Shenbailing granules in improving quality of life and reducing cancer-related fatigue in a real-world setting, with the goal of providing clinical evidence for the use of Shenbailing granules in alleviating cancer-related fatigue among post-breast cancer surgery patients.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: Subjects must meet all of the following enrollment criteria to be enrolled in this trial: 1. be 18-75 years of age (both 18 and 75); 2. female; 3. all patients have histologically confirmed breast cancer; 4. expected to receive surgical treatment; 5. expected survival of ≥ 1 year; 6. the level of function of vital organs must meet the following requirements: 1. Bone marrow function Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L; Platelets ≥ 100 x 10\^9/L; Hemoglobin ≥ 90 g/L; 2. Liver and kidney function Albumin level ≥ 3.0 g/dL; Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Alkaline phosphatase ≤ 2.5 x ULN; Urea nitrogen and serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min (calculated according to the Cockcroft-Gault formula); 3. Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 4. Echocardiogram (ECHO) showing cardiac left ventricular ejection fraction (LVEF) ≥ 50%; 8\. voluntarily accept the treatment and sign the informed consent form, have understood the purpose of this study and the experimental steps, good compliance, and comply with the relevant requirements of this trial protocol. Exclusion Criteria: 1. intolerance to or poor compliance with herbal medicines; 2. inability to swallow, chronic diarrhea and intestinal obstruction, and the presence of multiple factors affecting the administration and absorption of medications; 3. severe cardiac, hepatic, renal and other vital organ insufficiency; 4. combination of serious complications, active infection, persistent fever, serious bleeding tendency, hematopoietic function abnormality; 5. a known history of allergy to the drug components of this regimen; 6. have a history of immunodeficiency, including testing positive for HIV, HCV, active viral hepatitis B, or suffering from other acquired, congenital immunodeficiency diseases, or have a history of organ transplantation 7. a history of any cardiac disease, including (1) arrhythmia requiring medication or of clinical significance, (2) myocardial infarction, (3) heart failure, (4) any other cardiac disease judged by the investigator to be inappropriate for participation in the study, etc; 8. pregnant or lactating female patients, female patients of childbearing potential with a positive baseline pregnancy test or female patients of childbearing potential who are unwilling to use effective contraception throughout the trial period; 9. in the judgment of the investigator, have a serious concomitant medical condition that jeopardizes the patient's safety, or interferes with the patient's ability to complete the study (including, but not limited to, severe hypertension that cannot be controlled by medication, severe diabetes mellitus, active infection, etc.) 10. is unconscious, non-verbal or non-reading, unable to communicate normally, and unable to cooperate in completing the questionnaire assessment; 11. a previous history of a definite neurological or psychiatric disorder, including epilepsy or dementia 12. suspected or confirmed history of alcohol or drug abuse; 13. any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shengjing Hospital of China Medical University Shenyang Chian/Liaoning

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06881550 on ClinicalTrials.gov ↗ ← All trials in China