Myelosuppression after chemotherapy
Conditions
Interventions
Control Group:chemotherapy + conventional Western medicine supportive therapy
Treatment group:Yijing Yangxue Decoction + Moxibustion with ginger-separated + chemotherapy + conventional Western medical supportive therapy
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18–75 years, regardless of gender; (2) Patients with pathologically or cytologically confirmed stage III–IV lung cancer; (3) Scheduled to receive first-line platinum-based chemotherapy; (4) Expected survival = 3 months; (5) Platelet count = 90 × 109/L; (6) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0–2; (7) Voluntary participation in the study with signed informed consent.
Exclusion criteria
Exclusion criteria: (1) History of bone marrow-related diseases or severe underlying hematological disorders; (2) Previous receipt of platinum-based chemotherapy in the early stage; (3) Hypersensitivity to traditional Chinese medicine or moxibustion therapy; (4) Administration of other traditional Chinese medicine preparations (decoctions, formula granules, Chinese patent medicines, etc.) or health products with the effects of tonifying qi and nourishing blood within 4 weeks prior to screening; (5) Severe hemorrhage, uncontrolled systemic infection, or non-healing purulent and chronic infected wounds; (6) Uncontrolled comorbidities at screening, including hypersplenism, hyperthyroidism, hypothyroidism, connective tissue disease, etc.; (7) Intestinal obstruction precluding oral medication and requiring intravenous hyperalimentation; (8) Poorly controlled hypertension (treated resting systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg); (9) Poorly controlled diabetes mellitus (HbA1c > 8%), or severe diabetic complications such as proliferative diabetic retinopathy, history of renal transplantation, severe peripheral vascular disease (e.g., resulting in amputation, chronic foot ulcer, intermittent claudication); (10) Acute myocardial infarction within 3 months prior to screening, or cardiac diseases including unstable angina pectoris, arrhythmia requiring treatment, severe heart failure (New York Heart Association functional class > I), judged by the investigator to be ineligible for this clinical trial; (11) New-onset cerebrovascular accident (including ischemic stroke, hemorrhagic stroke, and transient ischemic attack) within 3 months prior to screening, judged by the investigator to be ineligible for this clinical trial; (12) Other severe systemic diseases that, in the investigator's opinion, could affect the evaluation of efficacy and safety in this study, including any respiratory, digestive, hepatic, renal, or hematological disorders; (13) Patients with severe psychiatric disorders or inability to comply with the treatment course; (14) Pregnant or lactating females; (15) Skin ulceration, rash, dermatitis, or other severe skin diseases at the moxibustion site; (16) Any other conditions deemed inappropriate for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute neutrophil count; | — |
Secondary
| Measure | Time frame |
|---|---|
| White blood cell count;Platelet Reduction Rate;Myelosuppression Grading Improvement Rate;The duration of grade =3 ANC decrease in the second cycle of chemotherapy.;The lowest ANC value during the first chemotherapy cycle.;The time required for the lowest ANC value in each cycle to reach above 1.8×10^9/L.;The incidence rate of fever and neutropenia (FN);Quality of Life Rating;TCM symptom score; | — |
Countries
China
Contacts
Public ContactYao Yu
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed