Cervical cancer
Conditions
Interventions
Control Group:Basic treatment + radiotherapy and chemotherapy
Research Group:Basic treatment + radiotherapy and chemotherapy + modified Shengmai Dihuang Decoction
Sponsors
Affiliated Hospital of Zunyi Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for early to mid-stage cervical cancer as per the "Guidelines for the Conservation of Fertility in the Diagnosis and Treatment of Early Cervical Cancer (2025 Edition)," confirmed through clinical presentation, gynecological examination, imaging studies, and histopathological biopsy as stage Ib to IIa. (2) Refers to the diagnostic criteria for cancer in "Guidelines for the Clinical Research of New Chinese Herbal Drugs (Trial)" and "Internal Medicine of Traditional Chinese Medicine," with a syndrome differentiation of Qi and Yin deficiency: main symptoms include fatigue, shortness of breath, reluctance to speak, dry mouth and throat, and heat in the palms, soles, and chest; secondary symptoms include soreness in the waist and knees, dizziness, tinnitus, spontaneous sweating, night sweats, constipation, and dark, scanty urine; tongue and pulse manifestations include a red tongue with little coating and a fine, rapid pulse. (3) Age between 18 and 65 years. (4) Karnofsky Performance Status (KPS) score =70. (5) Has undergone radical surgery for cervical cancer, with postoperative pathology confirming early to mid-stage cervical cancer, and with high-risk factors such as lymph node metastasis, vascular or lymphatic invasion, deep stromal invasion, or positive surgical margins. (6) Estimated survival =3 months. (7) No use of immunomodulators within the past 1 month. (8) Patients and their families have given informed consent and signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Subjects with other malignant tumors; (2) Pregnant or breastfeeding women; (3) Subjects with severe dysfunction of major organs such as heart, liver, or kidney (e.g., heart failure, cirrhosis, chronic renal failure, etc.); (4) Subjects with allergies to the study drugs (e.g., components of Shengmai Rehmannia Decoction, paclitaxel, cisplatin, etc.); (5) Subjects with mental disorders who are unable to cooperate with treatment and follow-up; (6) Subjects with active infections (e.g., sepsis, severe pneumonia, etc.); (7) Subjects with poor compliance who are unlikely to complete treatment and observation according to the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunological indicators: T lymphocyte subsets (CD3+, CD4+, CD8+) and CD4+/CD8+ ratio, natural killer cell levels, and immunoglobulin (IgA, IgG, IgM) levels;European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire score;TCM Syndrome Score;Adverse event rate; | — |
Countries
China
Contacts
Public ContactLiu Song
Affiliated Hospital of Zunyi Medical University
Outcome results
None listed