Breast Cancer
Conditions
Interventions
Test Group:Shenqi Shiyiwei Granules (oral administration) in addition to conventional therapy (including psychological counseling exercise guidance and dietary management)
Control Group:Oral administration of placebo in addition to conventional therapy (including psychological counseling exercise guidance and dietary management)
Sponsors
Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Female aged 18-75 years. Histologically confirmed hormone receptor-negative breast cancer (Stage I-IIIA) having undergone surgical resection and completed adjuvant/adjuvant intensive therapy =3 months prior with no signs of recurrence or metastasis. ECOG Performance Status (PS) score of 0-1. Moderate-to-severe fatigue-related symptom clusters defined as a MDASI-C Fatigue-Shortness of Breath-Pain subscale score =4. TCM diagnosis of Spleen Qi Deficiency Syndrome (per Traditional Chinese Medicine criteria). No prior targeted therapy for fatigue-related symptom clusters (fatigue dyspnea pain) before enrollment. No contraindications to exercise (e.g. venous thrombosis thrombocytopenia active infections). Capable of comprehension and communication with voluntary participation and signed informed consent.
Exclusion criteria
Exclusion criteria: Uncontrolled psychiatric disorders or moderate-to-severe cognitive impairment. History of hypersensitivity (e.g. allergic constitution prior adverse reactions to Chinese herbal medicine or confirmed allergy to Shenqi Shiyiwei Granules components). Expected disease progression of invasive breast cancer requiring radiotherapy during the study period. Comorbidities including: Other malignancies Severe cardiac hepatic or renal dysfunction (laboratory parameters exceeding twice the upper limit of normal [ULN]) Severe comorbidities (e.g. active infections significant bleeding tendency hematopoietic dysfunction). Active hepatitis B/C virus infection (HBV/HCV) HIV infection or primary/acquired immunodeficiency disorders. Pregnancy lactation or women of childbearing potential unwilling to use effective contraception. Current participation in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue-Shortness of Breath-Pain Symptom Cluster Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life Assessment;Quality of Life Assessment;Quality of Life Assessment;Functional Assessment;Quality of Life Assessment; | — |
Countries
China
Contacts
Public ContactGanlin Zhang
Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University
Outcome results
None listed