cancer-related fatigue
Conditions
Interventions
Fufang Lingzhi Anshen Oral Liquid group:Fufang Lingzhi Anshen Oral Liquid
Fufang Lingzhi Anshen Oral Liquid placebo group:Fufang Lingzhi Anshen Oral Liquid placebo
Sponsors
Taizhou Enze Medical Center (Group) Enze Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with non-small cell lung cancer diagnosed by pathology or cytology and inoperable; 2. Conforming to the diagnostic criteria of cancer-related fatigue, BFI score >= 4; 3. The investigators confirmed at least one measurable lesion according to RECIST 1.1 standard. If the measurable lesions located in the previous radiation field or after local treatment are confirmed to have progressed, they can be selected as target lesions; 4. Performance status (PS) score of the Eastern Cooperative Oncology Group (ECOG) was 0 or 1; 5. TCM syndrome was diagnosed as deficiency of qi syndrome; 6. Age 18-80 (including threshold), male or female; 7. The estimated survival time is more than 6 months; 8. Patients will receive chemotherapy combined with or without combined immunotherapy, and no less than 3 cycles; 9. Those who voluntarily accept the treatment of this scheme, can insist on the return visit according to the doctor's advice and have good compliance, and have informed consent and signed.
Exclusion criteria
Exclusion criteria: 1. Those with severe bleeding or systemic infection, and those with serious diseases of heart, liver, kidney and other systems; 2. Severe liver and kidney dysfunction; 3. There are histological components of small cell carcinoma, neuroendocrine carcinoma and sarcoma; 4. Patients with neurological and mental disorders accompanied by symptoms and difficult to control, and others who cannot complete the questionnaire independently or with the assistance of others; 5. Pregnant, lactating or planned pregnancy. Note: If there is a risk of pregnancy, male and female patients need to use efficient contraception, and continue until at least 180 days after stopping the trial treatment; 6. Those with allergic constitution or known to be allergic to the ingredients contained in the test drug; 7. Those who have participated in the clinical trial within three months before the trial or are participating in the clinical trial; 8. Patients with other malignant tumors; 9. Patients receiving erythropoietin, hypnotic drugs, melatonin, or Chinese patent medicines for supplementing qi; 10. There are medical history, disease, treatment or laboratory abnormal results that may interfere with the test results and prevent the subject from participating in the study in the whole process, or the researcher believes that participating in the study is not in the best interests of the subject; 11. In addition to the above, the investigator judged that the patients were not suitable for this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes in fatigue score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment effect of TCM symptoms; | — |
Countries
China
Contacts
Public ContactDongqing Lv
Taizhou Enze Medical Center (Group) Enze Hospital
Outcome results
None listed