Non-small cell lung cancer
Conditions
Interventions
Control Group:Radiotherapy + Placebo (Yanghe Dingchuan Plaster Placebo/Bufei Jiedu Granule Placebo)Yanghe Dingchuan Plaster Placebo: 45 g per dose, dissolved in hot water, twice daily
Bufei Jiedu Granule Placebo: 1 sachet per dose, dissolved in hot water, twice daily.
Experimental Group:Radiotherapy + Traditional Chinese Medicine (Yanghe Dingchuan Plaster/Bufei Jiedu Granule)Yanghe Dingchuan Plaster: 45 g per dose, dissolved in hot water, twice daily
Bufei Jiedu Granule: 1 sachet per dose, dissolved in hot water, twice daily.
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1.Meet the TCM diagnostic criteria for cough and dyspnea. 2.Fulfill the NSCLC diagnostic criteria outlined in the Chinese Medical Association's Clinical Guidelines for Lung Cancer Diagnosis and Treatment (2024 Edition). 3.Aged 40 years or older. 4.With an ECOG performance status score of 0 to 2. 5. Have at least one measurable intrathoracic lesion amenable to surgery or radiotherapy. 6. Have adequate organ and bone marrow function prior to trial participation, as evidenced by laboratory results obtained within 14 days before radiotherapy meeting the following criteria: a) Absolute neutrophil count (ANC) greater than or equal to 1.5 multiplied by 10^9/L; b) Platelet count greater than or equal to 75 multiplied by 10^9/L (without transfusion within 14 days); c) Hemoglobin greater than or equal to 90 g/L; d) Total bilirubin less than or equal to 1.5 times the upper limit of normal; e) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 times the upper limit of normal; f) Serum creatinine less than or equal to 1.5 times the upper limit of normal, OR Creatinine clearance greater than or equal to 50 mL/min; g) For patients not receiving anticoagulant therapy: Prothrombin time International Normalized Ratio (INR) less than or equal to 1.5 and Activated Partial Thromboplastin Time (APTT) less than or equal to 1.5 times the upper limit of normal. Patients on full-dose or parenteral anticoagulant therapy are eligible provided the anticoagulant dose has been stable for at least 2 weeks prior to study entry and coagulation parameters are within the therapeutic range specified by relevant guidelines; All other laboratory values from the screening assessments must meet the relevant standard criteria.
Exclusion criteria
Exclusion criteria: 1.Pathologically confirmed mixed small cell carcinoma component. 2.Expected survival time of less than 3 months. 3.Administration of Traditional Chinese Medicine (including herbal decoctions, physician-prescribed pills, or granules) within 14 days prior to enrollment. 4.Patients scheduled for surgery who have received any form of prior Western adjuvant therapy (including, but not limited to, radiotherapy, chemotherapy, immunotherapy, or targeted therapy). 5.Patients scheduled for radiotherapy who have a history of prior thoracic radiation. 6.History of other malignant tumors. 7.Cough and dyspnea caused by other factors such as infection or other systemic diseases. 8.Diseases with known etiology or specific pathological manifestations associated with airflow obstruction, such as cystic fibrosis or diffuse panbronchiolitis. 9.History of immunodeficiency, other congenital immunodeficiency disorders, or history of organ transplantation. 10.Presence of severe comorbid conditions that jeopardize patient safety or compromise the ability to complete the study. 11.History of chronic alcohol or substance abuse within 12 months prior to the visit. 12.Patients diagnosed with other infectious diseases such as tuberculosis, measles, or AIDS. 13.Patients with primary diseases or severe dysfunction of other vital organs (e.g., heart, liver, kidney). 14.Patients with severe neurotic disorders or mental illnesses. 15.Pregnant or lactating women. 16.Known allergy to any component of the investigational drugs, or history of severe allergic reactions to Chinese proprietary medicines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of traditional chinese medicine syndrome score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival;Incidence of radiation pneumonitis (RP); Eastern Cooperative Oncology Group Performance Status (ECOG PS) ;Visual Analogue Scale for Assessing Cough Severity;Pulmonary function;Serum level of lymphocyte subsets and cytokines; | — |
Countries
China
Contacts
Public ContactLu Zhenhui
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed