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The efficacy and safety of the Shugan Jianpi Formula in managing chemotherapy-induced adverse response in breast cancer patients with Liver-Qi Stagnation and Spleen-Deficiency Syndrome

The efficacy and safety of the Shugan Jianpi Formula in managing chemotherapy-induced adverse response in breast cancer patients with Liver-Qi Stagnation and Spleen-Deficiency Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001265
Enrollment
Unknown
Registered
2025-06-26
Start date
2026-03-01
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

The control group:The treatment protocol comprised proton pump inhibitors (PPIs) and gastric mucosal protective agents combined with either dual therapy (5-HT3 receptor antagonists plus glucocorticoid
The experimental group:The therapeutic regimen consisted of proton pump inhibitors (PPIs) and gastric mucosal protective agents, combined with either dual antiemetic therapy (5-HT3 receptor antagonist

Sponsors

Yanwei Wang
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Diagnostic Criteria: Patients were recruited according to the following diagnostic standards: 1. Breast Cancer Diagnosis:Based on the Chinese Anti-Cancer Association Breast Cancer Professional Committee and Chinese Society of Oncology Breast Cancer Group's *Chinese Anti-Cancer Association Guidelines and Standards for Breast Cancer Diagnosis and Treatment (2024 Edition)* [China Oncology. 2023;33(12):1092-1187]. 2. "Liver Depression and Spleen Deficiency" Syndrome Differentiation (TCM Pattern Diagnosis): Patients were required to meet the diagnostic criteria for "Liver Qi Stagnation and Spleen Deficiency" syndrome as defined in the Guidelines for Integrated Traditional Chinese and Western Medicine in Breast Cancer [Beijing Journal of Traditional Chinese Medicine. 2024;43(01):7-16]. Diagnostic Requirements: (1)Primary Symptoms (must present with =3): 1) Hypochondriac distension or pain 2) Emotional depression 3) Abdominal distension 4) Loose stools or constipation (2)Secondary Symptoms (must present with 1-2): 1) Distending pain in chest and hypochondrium 2) Frequent sighing 3) Irritability or tendency to anger 4) Poor appetite 5) Borborygmus or excessive flatulence 6) Abdominal pain relieved by bowel movement 7) Alternating diarrhea and constipation (1) Meeting the aforementioned diagnostic criteria; (2) Female aged 18-70 years; (3) No other traditional Chinese medicine drug treatments were administered; (4) Eligible to participate in this trial as assessed by relevant clinical specialists; (5) Voluntarily participating in the trial and signing the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with allergic predisposition; (2) Patients with severe cardiac, hepatic, or renal insufficiency or other systemic diseases; (3) Patients with psychiatric disorders or cognitive impairment who cannot cooperate with the study; (4) Patients currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Nausea and vomiting;Bone marrow suppression;

Secondary

MeasureTime frame
Karnofsky Performance Score,KPS;Tumor markers;Abnormal liver function;"Functional Assessment of Cancer Therapy - Breast (FACT-B) Quality of Life Score;Improvement of TCM syndromes;Tumor markers;

Countries

China

Contacts

Public ContactYanwei Wang

The Second Hospital of Lanzhou University

wangyw2003186@sina.com13619343312

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026