Study on Wenshen Shengbai Decoction Mitigating Chemotherapy-Induced Myelosuppression in Breast Cancer by Inhibiting Ferroptosis of Hematopoietic Stem Cells via the Nrf2/Gstp1/GPX4 Pathway

Authors
Category Primary study
Registry of TrialsInternational Traditional Medicine Clinical Trial Registry
Year 2026
INTERVENTION: Control Group:The treatment regimen for the control group follows the Guidelines for the Diagnosis and Treatment of Breast Cancer of the Chinese Anti‐Cancer Association. Postoperatively, chemotherapy is administered using the EC regimen: epirubicin 75–100 mg/m² by intravenous infusion, and cyclophosphamide 600 mg/m² by intravenous infusion. A chemotherapy cycle is 21 days, and four cycles are observed. For patients with a body surface area exceeding 2 m², the dosage is calculated based on 2 m².;Treatment group:The treatment group received oral administration of Wenshen Shengbai Decoction in addition to the chemotherapy regimen given to the control group. The herbal decoction was uniformly prepared by Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine. Each dose of the herbal medicine was concentrated into 200 mL and packaged in two bags (100 mL each). The decoction was administered orally twice daily (morning and evening), starting from the 7th day after each chemotherapy cycle until the day before the next chemotherapy cycle. A treatment course consisted of 14 consecutive days of administration, synchronized with the chemotherapy cycles. For both groups, white blood cell counts and neutrophil counts were measured on the 7th day after each chemotherapy cycle. If a patient developed myelosuppression of grade II or higher, rhG‐CSF was administered according to the Expert Consensus on the Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Myelosuppression Induced by Antineoplastic Drugs until white blood cell and neutrophil counts returned to normal levels. If myelosuppression reached grade IV or higher, necessary anti‐infective treatment was provided.; CONDITION: Breast cancer PRIMARY OUTCOME: White blood cell count; SECONDARY OUTCOME: Absolute neutrophil count;Platelet Count;Hemoglobin Count;Neutrophil count;Patient's rhG‐CSF usage;Interleukin‐2;Interleukin‐1ß;Interleukin‐6;Interleukin‐8;Interleukin‐10;Interferon‐alpha;Interferon‐?;Tumor Necrosis Factor;C‐reactive protein; INCLUSION CRITERIA: (1) Female, aged =18 years and =70 years; (2) Malignant tumor originating from breast tissue, pathologically diagnosed as breast cancer; (3) Patients requiring adjuvant chemotherapy with the (Epirubicin, Cyclophosphamide) regimen based on pathological findings and in accordance with the Guidelines for the Diagnosis and Treatment of Breast Cancer of the Chinese Anti‐Cancer Association; (4) Signed informed consent; (5) Meeting the diagnostic criteria for Yang deficiency pattern in traditional Chinese medicine.
Epistemonikos ID: 5217582e3451557a632750e5b912e952c53ee25b
First added on: Aug 10, 2026