Chemotherapy-induced bone marrow suppression
Conditions
Interventions
Control Group:Doxorubicin + cyclophosphamide followed by paclitaxel chemotherapy + placebo
Treatment group:Doxorubicin + cyclophosphamide followed by paclitaxel chemotherapy + modified Shenling Baizhu Powder
Sponsors
Xinxiang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for breast cancer: Based on the "Guidelines and Standards for the Diagnosis and Treatment of Breast Cancer by the Chinese Anti-Cancer Association (2021 Edition)". 1) A painless, hard, poorly defined, and mobile lump appears in the breast; some patients may also experience nipple discharge, nipple retraction, and orange peel-like changes in the breast skin; 2) Mammography reveals a mass and microcalcifications within the breast; 3) Breast ultrasound shows hypoechoic nodules with uneven echogenicity and irregular shape; 4) Pathological examination of the lesion tissue obtained through core needle biopsy, Mammotome biopsy, or surgical excision biopsy indicates breast cancer. (2) Meets the diagnostic criteria for spleen and kidney deficiency in Traditional Chinese Medicine: Based on the "Consensus on the Diagnosis and Treatment of Breast Cancer Using Integrated Traditional Chinese and Western Medicine". Main symptoms: soreness and weakness in the lower back and knees, fatigue, and pale complexion. Secondary symptoms: 1) cold limbs; 2) poor appetite and loose stools; 3) frequent urination at night; 4) shortness of breath and reluctance to speak. Tongue and pulse: pale and swollen tongue with a white coating, and a deep, thready, and weak pulse. Diagnostic criteria: The primary symptom is essential, and at least two secondary symptoms must be present. Diagnosis can be confirmed by referring to the tongue and pulse. (3) Received conventional chemotherapy regimens containing anthracyclines or taxanes, resulting in bone marrow suppression, i.e., peripheral blood leukocyte count <4.0×10^9/L, or neutrophil count <2.0×10^9/L, or platelet count <100×10^9/L, or hemoglobin <110g/L. (4) Age between 18 and 75 years; (5) Willing to participate in this study, signing an informed consent form, and able to cooperate in completing scheduled follow-up.
Exclusion criteria
Exclusion criteria: (1) Comorbid primary malignant tumors or severe hematologic disorders; (2) Severe diseases of vital organs such as the heart, liver, and kidneys, including heart failure grade III or above, Child-Pugh liver function grade B or above, and renal insufficiency; (3) History of autoimmune diseases, severe allergies, or immunosuppressant therapy within the past 3 months; (4) Pregnant or lactating women; (5) Patients with mental illness who are unable to cooperate with the study; (6) Patients who have used drugs that affect bone marrow hematopoietic function or immune function within the past month; (7) Patients allergic to the drugs used in this study (modified Shenling Baizhu Powder, placebo, chemotherapy drugs, granulocyte-macrophage colony-stimulating factor, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peripheral blood count indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune function indicators;Traditional Chinese Medicine Syndrome Scoring;Chemotherapy completion rate;Adverse reaction incidence; | — |
Countries
China
Contacts
Public ContactWang Zefeng
Xinxiang Central Hospital
Outcome results
None listed