Lung cancer
Conditions
Interventions
The test group:Health education + wall removal Ganoderma lucidum spore powder
The control group:Health education + placebo
Sponsors
Beijing Hospital of TCM, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Cell/histopathological diagnosis of non-small cell lung cancer; (2) After surgical pathology, chest enhanced CT, head enhanced CT/MRI, cervical/supraclavicular lymph node B-ultrasound /CT, upper abdominal enhanced CT/ B-ultrasound, whole body bone scan, and other imaging examinations, the clinical stage was determined to be IA. (3) Thoracoscopic sublobectomy with or without mediastinal lymph node dissection or systematic lymph node sampling was performed; (4) ECOG-PS score 0-1, and expected survival > 3 months; (5) Age 18-65 years old; (6) The patient has recovered from the toxicity of prior treatment, such as surgery or treatment for a disease other than NSCLC, and recovery is defined as grade 2 or below toxicity (except hair loss) according to the NCI-CTCAE. (7) The functions of the heart, liver, kidney, and hematopoietic system were normal; (8) Owning and skillfully using smartphones; (9) Women of reproductive age or sexually active male patients should take effective contraceptive measures before enrollment (after signing the ICF and within 3 months after the treatment period and the end of treatment); (10) Agree to participate in this study and sign informed consent.
Exclusion criteria
Exclusion criteria: (1) except that neoadjuvant or adjuvant therapy related to the diagnosis of primary cancer has been performed; (2) Patients who need to undergo other surgical procedures after changing surgical methods during the operation; (3) any known active autoimmune disease or history of autoimmune disease (e.g., but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects who had vitiligo or had complete remission of asthma in childhood could be included without any intervention as adults; Patients with asthma requiring medical intervention with bronchodilators are not included); (4) Patients requiring long-term steroid therapy or immunosuppressive therapy; (5) HIV-positive patients with active hepatitis B virus replication or active hepatitis (the diagnostic criteria for active hepatitis B are =1000copies/mL or 2000IU/ml of HBV-DNA, or low HBV-DNA quantity but positive HBsAg and/or HBcAb), active syphilis patients; (6) A history or concomitant presence of other malignancies other than completely cured non-melanoma skin cancer, cervical carcinoma in situ or other cured cancers (no evidence of recurrence for at least 5 years); (7) Complications from the following major diseases: cardiovascular disease (unstable angina, uncontrolled hypertension, myocardial infarction or ventricular arrhythmia or stroke within 6 months before starting standard chemotherapy, uncontrolled congestive heart failure or arrhythmia); Active severe infection or other serious complications; (8) Patients with cognitive dysfunction, communication disorder, or mental illness who cannot understand the research content; (9) Patients with severe postoperative hydrothorax and abdomen, subcutaneous emphysema, or other serious postoperative complications; (10) Pregnant or lactating women; (11) Known allergy to the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target symptom threshold number of events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Heart rate and blood oxygen mean;Pulmonary function test;MDASI-LC;BFI;EQ-5D; | — |
Countries
China
Contacts
Public ContactGuowang Yang
Beijing Hospital of TCM, Capital Medical University
Outcome results
None listed