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

A Single-center, Real-world Study of Shenbailing Granules in Patients After Breast Cancer Surgery

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Shenbailing

Detailed Description

This study plans to enroll patients who have undergone breast cancer surgery. The experimental group will receive Shenbailing granule therapy, with the primary objective of exploring the improvement of postoperative cancer-related fatigue and quality of life in breast cancer patients treated with Shenbailing granules. Patients will enter the real-world study phase immediately after surgery.

Experimental group: Adjuvant therapy with Shenbailing granules, starting from 1 day after surgery; Control group: Normal postoperative recovery without medication.

After confirming the surgery date, patients' quality of life, cancer-related fatigue, and breast cancer patient-reported outcome scales will be collected preoperatively, 1 day, 7 days, 14 days, and 28 days postoperatively to evaluate their quality of life and cancer-related fatigue. If patients are not tolerant to the medication, they will stop taking it.

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chian/Liaoning
    • Shenyang, Chian/Liaoning, China, 110022
      • Shengjing Hospital of China Medical University

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Normal postoperative recovery without Shenbailing granules
Experimental: TCM; Adjuvant therapy with Shenbailing granules, starting from 1 day after surgery	Drug: Shenbailing; Adjuvant therapy with Shenbailing granules, starting from 1 day after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Piper Fatigue Assessment score	The degree of cancer fatigue was assessed by piper Fatigue Assessment Scale	1 day, 7 days, 14 days, and 28 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EORTC QLQ-C30 score	Measure the quality of life of cancer patients in different physical and psychological aspects	1 day, 7 days, 14 days, and 28 days postoperatively
EORTC QLQ-BR23 score	Evaluate systemic treatment side effects, arm symptoms, breast symptoms, body image, and sexual function	1 day, 7 days, 14 days, and 28 days postoperatively

Collaborators and Investigators

• Sponsor: Caigang Liu

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Estimated): December 10, 2025
• Study Completion (Estimated): December 10, 2026

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SBL-RWS

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
• product manufactured in and exported from the U.S.: No