NCT06881550

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Caigang Liu · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Shenbailing	Adjuvant therapy with Shenbailing granules, starting from 1 day after surgery.

Timeline

• Start date: 2024-12-30
• Primary completion: 2025-12-10
• Completion: 2026-12-10
• First posted: 2025-03-18
• Last updated: 2025-03-18

Locations

1 site across 1 country: China